DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

DISTRICT ADDRESS ANO P HONE NUMBER DATE(S) OF INSPECTION

1 2 4 2 0 Parkl awn Drive, Room 2 0 3 2 1 /22/202 4 - 2/2/202 4*

Rockvi lle, MD 2085 7 FEJ NUMBER

3 00 8 4 61 61 9

NAME A NO Tm E OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shas tri, Pre s iden t - Operat i o ns

F IRM NAME STREET AOORESS

Eug ia Ph arma Spe c ial itie s Li mited 3 4 To 4 8 Plot No : 4, Unit - Iii; Ts iic
CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT IN SPECTED

Sa ngareddy, Te l a nga n a, 50230 7 I n dia Steri l e Dr ug Ma nufac t u rer

This document lists observations made by the FDA representative(s) dtu-ing the inspection ofyotu· facility. They are inspectional
observations, and do not represent a final Agency detel'lllination regarding yotu· compliance. Ifyou have an objection regarding an
observation, or have in1plemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or
action with the FDA representative{s) dm-ing the inspection or submit this information to FDA at the adch·ess above. If you have any
questions, please contact FDA at the phone ntunber and address above.

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

OBSERVATION 1
Procedures designed to prevent microbiological contamination of mug products pmpo1ting to be sterile
are not established and followed.

During aseptic filling operations, procedure HO-CQA-SOP-229 "Clean Room Practices and Aseptic
Behaviour" and line specific intervention procedures were not followed:
(b,{4 (b)1.Jj
I .During set-up and aseptic filling ofl Injection batch l (US market) on
Januaiy 20, 2024, the following was observea:

a.An operator perfo1med an l t"JT1 intervention at approximately (b)1<1 for j (bTC, tubing
adjustment (Intervention C43). The operator was supposed to perfo1m the interventiol!_
4
(bH j so they did not need to reach over the fill line, but insteadj
4
from! (bH)
which required them to lean over the conveyor. The operator did not first sanitize their
hands before entering the filling baITier. The operator leaned over open vials that were
still present on the line at the time of the intervention. Not all exposed vials were
remo_yed. This intervention was not documented and perfo1ming this intervention from
l (bT'4} has not been evaluated in smoke studies or media fills.

·cbJ(4l
b.An intervention was observed at the stopperin.d(l:5 -(~) !that required an l
intervention at approximately 10:14 to cleai· broken vials. The operator used a forceps
brought from the Grade B ai·ea into Grade A to clear vials without first sanitizing it. Then

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FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE I of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

12420 Parklawn Drive, Room 2032 1 /22/2024 - 2/2/2024*

FEJ NUMBER
Rockville, MD 20857
3008461 61 9

NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shastri, President - Operations

FIRM NAME STREET AOORESS

Eugia Pharma Specialities Limited 34 To 48 Plot No : 4, Unit - Iii; Tsiic

CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Sangareddy, Telangana, 502307 India Sterile Drug Manufacturer

the operator directly used their hand on sterile pa1t s of the stoppering((l5) (4)]and on the
conveyor. This intervention was not recorded in the batch record. It had not been
previously covered in a smoke study or media fill. No personnel monitoring finger dabs
were collected at the end of the intervention.

c.An l (bTC, intervention was perfo1med at a1mroximately 10:17 that included putting a
zip tie on the tubing connected to the I (b>1 j The operator perfo1med the
4

4
intervention while reaching over the exposed (bJC This intervention was
inaccurately recorded in the intervention recora as C46 (b) 4) I adjustment), which
does not include installing zip ties and does not require the operator to work directly
above the I t"JT1

cl.During interventions at the vial I (b1:'.] to remove broken or fa llen vials, the operator used
the RABS (bJ dire over open vials that were not subsequently removed. The RABS
r(bT(4l·1 are removed {6}(, £ I
or {6}(', but oth e1w 1•se remam
• on th e 1·me where
they are sanitized, but not sterilized. The intervention record under repo1ted the number
of times this intervention occun ed.

When glass breakage occmTed and generated glass pa1t iculate during this inte1vention,
the operator did not remove smTounding vials that could have been contaminated with
glass paiticles. Glass breakage was obse1ved during inte1ventions at approximately 1 (b11 1
I (bH"i There were no entries in the inte1vention record of any glass breakage
during filling of the batch.
,Y-(4
e.An operator reached the RABS over stoppers and the sterile stopper bowl at
approximately 13:34. This inte1vention (C3 1) was not recorded in the inte1vention record.

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OF THIS PAGE Eileen A Liu, Investigator - Dedicated Drug .........
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Anastasia M Shields, Investigator

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 2 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVI CES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2 4 2 0 Parklawn Drive, Room 2 032 1 /22/2024 - 2/2/2024*

FEJ NUMBER
Rockville, MD 20857
300 8 461 61 9

NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shastri, President - Operatio ns

FIRM NAME STREET AOORESS

Eugia Pharma Specialities Limited 34 To 48 Plot No : 4, Unit - Iii; Tsiic

CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Sangareddy, Telangana, 502307 India Sterile Drug Manufacturer

f. Following set-up and before the sta1t of filling, an operator perfo1med an l (bTC,
4
intervention (C16) to adjust the filling machine at approximately (b)1 working directly
above the expo~edl (b)1] The operator unnecessarily left the baITier! {6)1
of the I (bT'i open wfien gomg to a different pa1t of the filling room.

1
g.Liquid was observed below the conveyor near the vial l (b11 area. The operators did not
take action to address the liquid, dete1mine the source, or document the occmTence in the
batch record.

2.During set-up and aseptic filling ofl (b)l, batch ! l

(bT(4 (US market)
on Januaiy 21 -22, 2024, the following was observed:

a.An operator reached a RABS {6,(l over the I (b)l1 and openl (b>1-4j durin!h,
interventions at approximately 8:10 and 8:26. The RABS l (b)14-l are removedl (b ,
I C6Tc1 for I {"ff1 but othe1wise remain on the line where they are sanitized, but not
4
sterilized. The exposed ~>1 were not removed. This intervention was not established
in the smoke studies or meaia 111.

b.An operator perfo1med an intervention (Cl 1) by reaching the RABS (b)l4l directly over
sterile stoppers and the sterile stopper bowl to clear stopper jams. This occuITed
approximately 16 times during the batch, but was only documented in the intervention
record 3 times.

c.During installation of the stopper bowl, the hands of the operator were directly over the
sterile stopper bowl.

3.During set-up and aseptic filling ofl • n batehI

(b)144j In.Ject10 (b)144j (US mai·ket) on Januaiy

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OF THIS PAGE Eileen A Liu, Investigator - Dedicated Drug .........
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Anastasia M Shields, Investigator

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 3 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2 4 20 Parklawn Drive, Room 20 32 1/22/202 4 - 2/2/2024*

FEJ NUMBER
Rockville, MD 20857
300 8 461619

NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shastri, President - Operations

F IRM NAME STREET AOORESS

Eugia Pharma Specialities Limited 34 To 48 Plot No : 4, Unit - Iii; Tsiic

CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Sangareddy, Telangana, 502307 India Sterile Drug Manufacturer

21-22, 2024, the following was observed:

(bY{4
a.During an l (bY{-4l intervention (C38) to remove fallen vials at approximately on
Januaiy 24, 2024, an operator reached over open vials that were not subsequently
removed. This intervention was not documented in the intervention record.

b.During set-up activities, the operator had their hands foreanns and head in the Grade A
area and directly above the exposed sterile I Cb1l,

c.Durin~ interventions (C3) at the vial l (bY{-4i the operator extended the RABS
1
l (b' over open vials that were not subsequent1y removed.

cl.During interventions at the stopper bowl (C54), the operator used the RABSl 1
(b11 over
exposed sterile stoppers and the surfaces of the stopper bowl.

{6ff,
4.During set-up and as~~tic filling ofl CbTC1 Injectable Suspension
4
Vial batch l (b) j (US mai·ket) on Januaiy 17-18, 2024, the following was observed:

a.During an ~ ~ intervention (C39) to cleai· jammed stoppers on the stopper track, the
operator reac e over exposed stoppers and the sterile surfaces of the stopper track with
their hand and aim . A second operator using a RABS 1 (b11 reached over open, filled 1
vials and moved their hand rapidly near open vials.

b.During interventions (Cl ) to remoye jammed and fallen vials in the incoming vial area, the
operator reached the RABS I CbT'i over open vials. Exposed vials were not removed.
These interventions were not documented in the intervention record.

EMPLOYEE($) SIGNATURE DATE lSSUEO

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OF THIS PAGE Eileen A Liu, Investigator - Dedicated Drug .........
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Anastasia M Shields, Investigator

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 4 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2 4 2 0 Parklawn Drive, Room 2 032 1 /22/2024 - 2/2/2024*

FEJ NUMBER
Rockville, MD 20857
300 8 461 61 9

NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shastri, President - Operatio ns

FIRM NAME STREET AOORESS

Eugia Pharma Specialities Limited 34 To 48 Plot No : 4, Unit - Iii; Tsiic

CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Sangareddy, Telangana, 502307 India Sterile Drug Manufacturer

c.During an intervention to adjust the stopper holder (C32), an operator took a wipe, which
had been used to wipe a tool in the Grade B area and was on a caii in the Grade B area,
and passed it into the Grade A area. It was then used to wipe the conveyor neai· open
vials.

cl.During installation of the stopper bowl, the operator repeatedly touched the sterile contact
surfaces of the stopper track that move the stoppers to the fill line.

5.During aseptic filling ofl (b111 Injection batch ! (b111(Canada market) on Januaiy
18, 2024, the following was observed:

a.During an intervention to remove a jammed vial at approximately 8:13, the operator

forcefully shuck a vial with the forceps, causing it to break. No vials in the area were
removed and there was no documentation of the intervention or glass breakage. The
RABS 11
l (b 1
were observed directly over other open vials that were not removed during
this intervention.

b.During an intervention (Cl 7) for adjustment of the[(l:5) (,4) I near the stoppering station,
the operator placed a black [(l:5) (-4) Jwhich is sanitized, but not sterilized, on the
sterile stoppering(I::>) (4 ~ TliIS mtervention was not documented.

c.Liquid was observed below the conveyor near the vial1 (b111 ai·ea . The operators did not
take action to address the liquid, determine the source, or document the occmTence in the
batch record.

• mac~h'me setup on L'me r:") pn•or to aseptic

6.Durmg • fill' ~
1 mg of bate (b1:}
[ (b) ~ Solution ! (b)<1mL, an operator perfo1med an (b><4 mtervention to mstaII tlie

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OF THIS PAGE Eileen A Liu, Investigator - Dedicated Drug .........
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FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 5 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVI CES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2420 Parklawn Drive, Room 2032 1 /22/2024 - 2/2/2024*

Rockville, MD 20857 FEJ NUMBER
3008461 61 9

NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shastri, President - Operations

FIRM NAME STREET AOORESS

Eugia Pharma Specialities Limited 34 To 48 Plot No : 4, Unit - Iii; Tsiic

CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Sangareddy, Telangana, 502307 India Sterile Drug Manufacturer

4
stopper WCl in the Grade A area . The operator was using their hands to uncover the Cb>1
bowl and then placed their hands directly inside the WCl where they were observed touching
the inside walls and base of the (b)~ The inside of this CbTCl comes in direct contact with
sterilized Cb)l4l stoppers used to seal.aseptically filled via s.

OBSERVATION 2
Laborato1y records do not include complete data derived from all tests, examinations and assay
necessa1y to assure compliance with established specifications and standards.
4
1. The Line _._,,,__... CbTC4l contains a total of CbTC4l and integrity testi!}§ of all (bH is
perfo1med after CbH4l ba ch. Review of CCTV video recordings showed (b)( integrity testing
4 4
was not perfo1med on Cb>1 during post fill Cb>1 ~ integrity testing associated with
4
aseptically filled .,___ {bTCl ~Injection batches Cb>1 and CbT<4l
[ Cb>1"] lnJect1on 6atcfi (6): ) (all U.S. batches . However, passmg integn ty test
4
results were generated for all CbH that were not tested.

Production r rs;nnel stiled they repeatedly test the same oo• while assigning oo• IDs
from other Cb)l4l that are not actually tested. This practice was observed to nave occuned
following batch CbTC4l (2 out of the CbTC4l were actually tested), batch CbTC4l (4 out
of the ! CbT( I were actually tested), and batch
4
Cb>1 (10 out of the
4
CbH were
actually tested). Production personnel stated not all CbH4l were tested because some of the Cb)l4l
(b)14
would not pass.

On Janua1y 26, 2024, WCl did not pass after three attempts to integrity test it, resulting in
4
a product non-confo1mance investigation. The Line'Cb>1 Assistant Manager for Production stated
4 4
that no previous Cb>1 integrity failures were repo1ied for Line Cb>1 from November 2019 to date.

2. Environmental monitoring data worksheets for Grade A swab surface monitoring associated with

EMPLOYEE($) SIGNATURE DATE lSSUEO

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Anastasia M Shields, Investigator

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 6 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVI CES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2420 Parklawn Drive, Room 2032 1 /22/2024 - 2/2/2024*

Rockville, MD 20857 FEJ NUMBER
3008461 61 9

NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shastri, President - Operations

F IRM NAME STREET AOORESS

Eugia Pharma Specialities Limited 34 To 48 Plot No : 4, Unit - Iii; Tsiic

CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Sangareddy, Telangana, 502307 India Sterile Drug Manufacturer

• 11y fill
aseptica i ed ______ rn·~ection
,y-c4 _ • batehes _________..,. (b>1" and (b1141
I 4
(b>1 J Injection batch (bH4l (all U.S. batches), documented collectio!l of samples
that were never taken. IPQA personnel confnmed swabbing of Grade A
equipment surfaces was not erfoimed. There are a total oftlimlswab samplin locations including
J
tools and

but not limited to "on the (D) (4) (bTC4l ' (6) (4) ",
and "on the (6) (4) near IPQA personnel confnm ed the unexposed
' u" ~

swabs were delivered to the Microbiology QC laboratoiy for processing, incubation, and
enumeration. Results of the swabs were reviewed and released with no repoiied growth for
1141 1141
batches (b>1il and (b and (b despite sampling that did not occur.

3. Environmental monitoring data worksheets for Grade A (bT<4l surface

monitorin (b)C4l associated with ase tically .filled 'u"] Injection batches
and \UJ\~ (b)(4l Injection oaten (b)(4) (all U.S. batches),
..,..-----,,--=----
documented collection of samples that were never taken. IPQA personnel confnmed that only 10
1141
out of the (bT<4l were sampled for batch W(l None of the (b were sampled for
1141
either batch W(l or batch (b . IPQA personnel stated all (b) <4 media plates (used
and not used for sampling) were delivered to the Microbiology QC laboratoiy for incubation and
enumeration. Results for these plates were reviewed and released with no repoiied growth for
_ and_ _ _<6H4l
batches _ _ _{lir(4 _ and____ (bT(4l ·
despite ·
sampling ·
that did not occur.

4. b 4 non-viable paiiicle counts (NVPC) taken in Grade A and Grade B aseptic processing
areas ai·e repoiied without collecting samples in the documented locations.

a. Production ersonnel involved in Line c' filling (b)1il Injectable

Suspension (b>1il Vial batch _ __(b>1il (US mai·ket) on Januaiy 17-18, 2024,
stated (D) (4 Graae A and Grade B non-viable paiiicle count samples ai·e not taken in the
fill room at the documented sample locations. Rather, they are taken from a b) <4 in the
aseptic conidor outside of the filling room. These samples are taken after the

EMPLOYEE($) SIGNATURE DATE lSSUEO

SEE REVERSE Justin A Boyd, Investigator 2/2/2024

OF THIS PAGE Eileen A Liu, Investigator - Dedicated Drug
Cadre
Anastasia M Shields, Investigator

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 7 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

12 420 Parklawn Drive, Room 2032 1 /22/2024 - 2/2/2024*

FEJ NUMBER
Rockville, MD 20857
3008461 61 9

NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shastri, President - Operations

F IRM NAME STREET AOORESS

Eugia Pharma Specialities Limited 34 To 48 Plot No : 4, Unit - Iii; Tsiic

CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Sangareddy, Telangana, 502307 India Sterile Drug Manufacturer

con esponding aseptic filling activities have occmTed. To get the time and date that
appears on the NVPC printout to match, the operators change the time and date on the
NVPC instIUillent by backdating it to when the sample should have been collected.

A production operator stated the samples are taken in the aseptic coITidor 6TT4 'because
the tests do not always pass when taken in the filling room at the designated locations.
The operator acknowledged there have been previous failing results that were not
repo1ied. These failing printouts were discarded and the tests were repeated in the aseptic
coITidor 6TT4

A production supervisor for aseptic filling Lines ~ and (b,{4 stated he was aware of this
ongoing practice for the past year. He stated he mitially mstiucted employees to take
samples in the aseptic coITidor when the NVPC device was not ftmctional because it was
not charged. He acknowledged production employees continued the practice.

b. Producti~n personnel involved in LineCbT(l~ 1lling I (bY{il1 batch

Cb)C, (US market) confnm ed the (b) (4 Grade A and Grade B nonviable pa1i icle
count sam;eles were not taken in the filling room. Samples were taken in the aseptic
coITidor {6) (4): but documents were made to indicate they were taken in the filling room
by changing the time and date on the NVPC instIUillent.

C. Production personnel responsible:~ or (l 15) (4 JNVPC monitoring during the filling of

D) (~) !Injection, Batch \• H ~ (US market), on Januaiy 18, 2024, stated

NVPC samoles for the grade B ai·ea of Line'~ Bloc{ ~ were actually collected in the
b) {4) I and not in the filling room m the designated sample locations. The
operators changed the time and date on the instI11ment by backdating it to when the
sample should have been collected to get the time and date to match for repo1i ing in the
records.

EMPLOYEE($) SIGNATURE DATE lSSUEO

SEE REVERSE Justin A Boyd, Investigator 2/2/2024

OF THIS PAGE Eileen A Liu, Investigator - Dedicated Drug .........
~ - Dedlc-.:IOT.g
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=~~
Cadre X 12SS(16

Anastasia M Shields, Investigator

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 8 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVI CES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2420 Parklawn Drive, Room 2032 1 /22/2024 - 2/2/2024*

Rockville, MD 20857 FEJ NUMBER
3008461 61 9

NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shastri, President - Operations

F IRM NAME STREET AOORESS

Eugia Pharma Specialities Limited 34 To 48 Plot No : 4, Unit - Iii; Tsiic

CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Sangareddy, Telangana, 502307 India Sterile Drug Manufacturer

Interviews with production personnel and recordings of previous media fills demonstrate this is
an ongoing practice. Media fills perfo1med in September 2022 (Bloc11 ~1 Line ~ >J<-O April 2023
r~~ ~
(Block ~ Line (ti}(' Se~tember 2023 (Block r~
~ Line (6r(4 November 2023 (Block "'<4 Line (6)~(4 and
4
December 2023 (Bloc~ Line C6>1 similarly showed NVPC samples were not taken at the times
and locations documented in the records.

5. (6) (4 )non-viable (D) (4 air samples taken in Grade A and Grade B aseptic processing areas are
submitted to the microbiology laborato1y without exposin~ lates at the specified locations.
Samples are collected in an aseptic conidor l:>f{.i:J' o 6 4 instead of the specified
locations in the filling room. Records are made to appear as if the samples were collected at the
specified locations and times in the filling room. For example:

a. IPQA personnel involved in moni[ ring during "'11.q Injectable

Suspension <1'>14 Vial batch <1'>14 (US market) on Januaiy 17-18, 2024,
4 air sampling aocumented in the records, including both Grade A
and Grade B sample locations, were not exposed in the filling room at the documented
locations.
<1'T
b. IP~ ersonnel involved in monitoring during batch
<1'T<1 (US market) on Januaiy 21-22, 2024,_ , c-o-n""'
fn_ d (b) {4)
" m_e..,.., air sampling
...d.,-o-cum
- -en_t,....ed in the records were not exposed in the filling room at t e documented
locations.
4
c. IPQA personnel involved in monitoring durin <1'>1" batch ~ Tc J (US
market) on Janua1y 20, 2024, confnmed (6) (4) air samp ing d o ~ m the
records were not exposed in the filling room at the documented locations.

EMPLOYEE($) SIGNATURE DATE lSSUEO

SEE REVERSE Justin A Boyd, Investigator 2/2/2024

OF THIS PAGE Eileen A Liu, Investigator - Dedicated Drug
Cadre
Anastasia M Shields, Investigator

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 9 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVI CES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2 4 20 Parkl awn Drive, Room 2032 1 /22/202 4 - 2/2/202 4*

Rockvi lle, MD 2085 7 FEJ NUMBER
3 008 4 61 61 9

NAME ANO Tm E OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shas tri, Pre s iden t - Operat i ons

F IRM NAME STREET AOORESS

Eug ia Pharma Spe c ial itie s Li mited 3 4 To 48 Plot No : 4, Unit - Iii; Ts iic
CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT IN SPECTED

Sa ngareddy, Te l a nga n a, 50230 7 I ndia Steri l e Dr ug Ma nufac t u rer

d. IPQA personnel involved in filling (6) (4) Injection, batch t"Yr4 l(lIS
4
market), on Janua1y 18, 2024, stated th~ samples from sampling points (b)1

[ .- .-.-----. =::) in the Grade B area of Block ~;~Line c;1were

not exposed m tfie fil mg room at tfie documented locations. Instead, these samples were
taken in the Ko) (4) I
These samples were submitted to the laboratory and
placed on incubation without ever being exposed to the environment in the filling room.

Interviews with IPQA personnel and recordings of previous media fills demonstrate this is an
ongoin~ practice. Media fills perfo1med in September 2022 (Block , Line CtiHj April 2023
{6}(' iJ(4~ hlrmo, r:T(4J
(Block <(b4 Lme
•
September 2023 (Block <(b~ •
4 Lme ~ mber 2023 (Block <(b4 Lme
•
and
1
December 2023 (Block [lliLine (b)14 similarly showed (t>) (4)air samples were not taken at the
times and locations documented in the records.

6. Review of the CCTV footage from Block (rarevealed that on Janua1y 18, 2024, operators were
observ.ed perfo1ming post filling, environmental surface monitoring of the Grade A RABs. w~j
used to perfo1m interventions during ase tic fillin . Per SOP E3 -QC-MIC-GEN-0014, the (b)J
11 41 11 41
(b are to touch the media plate ...___,,_ _ _ _ _,,_,_,, (b Tfie
RABs CtiH being sampled were observed to never touch the (b) <4 plate. For example:

a. Bloc~ Line ~ (CCTV CAM2) the RABs (b)C-0 was placed just above the surface of the
b) <4 never touchin the late. Monitoring was associated with aseptically filled batch
(b) (4) Injection, US market.

b. Bloc~ Line ~1(CCTV C.AM3) the RABs (b)C-0 was observed over the Kb) <4 lplate during
EM monitoring, the (b)C-O never touching tfie plate .. Monitoring was associated with
4
aseptically filled batch (b)1 Inj. US market.

7. For surface swabbing SOP E3-QC-MIC-GEN-0014, "The sampling area covered should be

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Cadre
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FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 10 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO P HONE NUMBER DATE(S) OF INSPECTION

12 4 20 Parkl a wn Drive, Room 2032 1 /22/2024 - 2/2/2024*

Rockvi lle, MD 2085 7 FEJ NUMBER

3008461 61 9

NAME ANO Tm E OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Sha s tri, Pre s iden t - Ope r ations

F IRM NAME STREET AOORESS

Eugia Ph arma Spe c ial itie s Li mited 3 4 To 4 8 Plot No : 4, Unit - Iii; Ts iic
CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT IN SPECTED

Sa ngareddy, Te l a nga n a, 50230 7 I n dia Steri l e Dr ug Ma nufac t u rer

greater than or equal to rncm 2 but no larger than ~ cm2 or sampling shall be done such that it
covers the maximum surface of the intended location." Review of the CCTV footage from
Block ~1Line ~c~ CAM3, from Januaiy 18, 2024, showed an operator performing Grade A swab
sampling on t e tweezers used to perfo1m interventions on open sterile unfilled vials that are
used to hold the aseptically filled diug product. Post filling of Batch I lbT<1
l lb)C, Inj . US market, the operator did not touch the surface of one side of the tweezers with
the swab and only touched a small section of the other side of the tweezers with the swab.

8. Production personnel only print the passing (bT(4l mtegn • • resu1ts. If th ere are f:a1·1ures,
•ty testmg
leaks, intenupted tests, or ala1m s, the results ai·e not printed to be included with the batch record
for QA review. For example:

a. Line
{6,(l
post (b)l 4l mtegn
. .ty Dor I 4
1
CbTC Injection batch I lb)l 1 failed
to include two failing and two leaking results.

b. Line (bY{-4 post (bY{-4 integrity for I lbTc4 Injection batch I lb)l 4 failed to
include one failing, four intenupted, and three alaims.

9. During processing of chromatograms, only the final version of the chromatogram is being saved
after application of manually entered timed integration events.

OBSERVATION 3
Batch production and control records do not include complete info1mation relating to the production and
control of each batch.

1. Production personnel used the "Check List for Verification of Product Contact Pa1t s for LineJC6T1
to document the1 C6Tc1 stopper! lbT<, bowl (IVFSM-001/S0l 7) and the cap I lb)l , bow
(IVCPM-001/S006) were removed, washed, andl we, before being used in the Grade A

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FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 11 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVI CES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2420 Parklawn Drive, Room 2032 1 /22/2024 - 2/2/2024*

Rockville, MD 20857 FEJ NUMBER
3008461 61 9

NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shastri, President - Operations

FIRM NAME STREET AOORESS

Eugia Pharma Specialities Limited 34 To 48 Plot No : 4, Unit - Iii; Tsiic

CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Sangareddy, Telangana, 502307 India Sterile Drug Manufacturer

Cb>14 £or th e ase~tlc

• fi1ll'_!ng of _____ CbTc4l rn· . batehes
~ect1on Cb>14
and •"• Injection batch 00 " (all U.S. bates)-. __R __e_v.,.ie_w_ o..,
f __C__C....TV
--
showed the stopper bowl and cap bowl were not removed from the CbTCl during the
disassembling step. Production personnel confnmed they had not per 01m ed the bowl
disassembly, washing, or sterilization between these batches.

2. Per SOP EP3-PR-SOP-048-00, Bloc¾(b11, Line r Cb)l4l are cleaned _ _ _ CbT, of

Cb>14lfilling activity. Thee-log cleaning records aocument spec1 1c times the ,.,,~ were cleaned
for
(br(4 .
of the aseptically filled batches
(bT(4) I (tif(4J;
~- - and ...-,--,=---,-...
(b)( .
J and _ _ _.,.- Review of
CCTV recordings showed none of the CbH-4 were cleaned. Production personnel confnmed they
4
did not clean any of theF lGrade A CbH4l associated with these batches.

3. E-log cleaning records documented cleanin activities includin mo~~in~ disinfection, WCl
rinse, and sanitization for the Bloc~ Line Cb> vial filling &
stoppering machine (PN-IVFSM-001), and vial sealing machine PN-IVCPM-00ll Review of
CCTV r~cordings associated with aseptically filled batches CbT( , and
(bJ showed most of these cleaning activities were not perfo1med. Product10n personnel
__m_e_d they did not follow the cleaning SOP for Line ltiH4 cleaning and they made up the time
-c-on__,f,i11_
spent for each cleaning activity documented in thee-log.

4. Review of the intervention records showed production personnel did not document all
interventions or document interventions accurately. Production personnel inside the aseptic
filling room do not have records. Inte1vention records are supposed to be documented by a
production operator located outside of the production room continuously watching live activities
from the CCTV camera . Production operators stated they may stop watching to perfo1m weight
checks or to take bathroom breaks, with no alternative person recording while they are not
present. Review of recordings identified the following batches had inte1ventions that were not
recorded:

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Anastasia M Shields, Investigator

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 12 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

12420 Parklawn Drive, Room 2032 1 /22/2024 - 2/2/2024*

FEJ NUMBER
Rockville, MD 20857
3008461 61 9

NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shastri, President - Operations

FIRM NAME STREET AOORESS

Eugia Pharma Specialities Limited 34 To 48 Plot No : 4, Unit - Iii; Tsiic

CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Sangareddy, Telangana, 502307 India Sterile Drug Manufacturer

a. CbT~ batch I
Cbnj cus market) . There were 24
mtervenhons not recoraea. Tliis includef ~~new mterventions that would have required a
product non-confo1mance investigation. CbT<4l~i is the maximum pe1mitted times for
4
j
interventior C 1), clearing of jammed
4
Cb>< stoppers. The intervention record only
documents Cbn occunences, but the intervention occmTed approximately 13 more times
that were not documented. This would have exceeded the pe1mitted number of
interventions and required a product non-confo1mance investigation.

b. Cbn"l Injectable Suspension ! CbT<, Vial batch l CbT<, (US

Market) had 21 interventions that were not recorded. This included six instances of
clearing of jammed vials with ~ PN-GP005, which is a new intervention that would
require a product non-confo1mance investigation.

C. ~ (~) Jinjection f]mg/mL batch( CbT<4l and batch l Cbn" (US

marlcet) nad a total of 97 interventions not recordeduilillmg and I CbH1 record.

d. {6) (~) !Injection USP (b1141mg/vial, batches! ~ and

'u" ) . (US market), had a total of 167 interventions not recorded in filling and
(bf<, record.

e. CbT"'} Injection bate~ CbT, (US market) had 12 interventions that were
not recorded.

f. CbT"'} Injection batch ! CbT"'} (US market) had 7 interventions that were not
recorded.

EMPLOYEE($) SIGNATURE DATE lSSUEO

SEE REVERSE Justin A Boyd, Investigator 2/2/2024

OF THIS PAGE Eileen A Liu, Investigator - Dedicated Drug ..........
~ - Dedlc-.:IOT.g
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=~~
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Anastasia M Shields, Investigator

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 13 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2 4 2 0 Parklawn Drive, Room 2 032 1 /22/2024 - 2/2/2024*

Rockville, MD 20857 FEJ NUMBER

300 8 461 61 9

NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shastri, President - Operatio ns

F IRM NAME STREET AOORESS

Eugia Pharma Specialities Limited 34 To 48 Plot No : 4, Unit - Iii; Tsiic

CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Sangareddy, Telangana, 502307 India Sterile Drug Manufacturer

OBSERVATION 4
Procedures designed to prevent microbiological contamination of mug products pmpo1ting to be sterile
did not include adequate validation of the aseptic process.

1. Block~ Line l (bT(4l·1 re-qua1·fi . an d

1 1cabon
lbTC4l
exposure were not adequately
perfo1med:

a. During [ (b:~ re-qualification, Chemical IndicatorsC l} j nd Biological Indicators (BI} .

were not p aced at the worst case location of each lb)<4l Folds in th~ lb)<,
{lir(4~
sections of the were observed. However, CI and BI were placed only on the smooth
sur £ace o f each •
dm·m \ UJ\-11 c:i"
qua11·fi1cabon
• eye1es.

b. There is no writt~ n rocedure on h.ow . to Fse lhT<4} appropriately to pre~ th 7

I 11
lb
11
1
for lb 4L_cycles. Paitially lb)<1
• the
an dfioIds m • i__:j pn.or to commercia
w", ai·eas were seen rece1•vm .1
manufacturing.

2. The following deficiencies were observed during review of air flow visualization studies (smoke
studies):

a. Smoke studies for Bloc~ Line I lh>1"j was not conducted under dynamic
condition. Although vai·ious interventions were perfo1med, the filling line remained static
and did not simulate the commercial Il!anufacturing condition. For example, removal a
fallen vial was simulated at the I lhT<4} location. The operator removed a fa llen vial that
□ed next to a few standing vials. However, under the tiue dynamic condition, the
would be filled with empty vials and moving.

b. For the Bloc~ Line I lhT<4} the operator 's activities in [( b) (4) !sterile l lbT(1

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=~~
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Anastasia M Shields, Investigator

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 14 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVI CES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2 4 20 Parkl awn Drive, Room 2032 1 /22/202 4 - 2/2/202 4*

Rockvi lle, MD 2085 7 FEJ NUMBER
3 008 4 61 61 9

NAME ANO Tm E OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shas tri, Pre s iden t - Operat i ons

F IRM NAME STREET AOORESS

Eug ia Pharma Spe c ial itie s Li mited 3 4 To 48 Plot No : 4, Unit - Iii; Ts iic
C ITY. STATE. Z IP CODE. COUNTRY TYPE ESTABLISHMENT IN SPECTED

Sa ngareddy, Te l a nga n a, 50230 7 I ndia Steri l e Dr ug Ma nufac t u rer

sto2,~ers obstructed the path of unidirectional flow (first air) by reaching their aim over
the I
4
Cb>1 1The operator also created turbulent air when he shook the canister in quick
and short motions to release 1 Cb>11 stoppers to the 1 CbTc4

c. 0 n fill
1 mg . 1abon
. L.me C(b4 th e s1mu . of removmg
. a Jamme
. d Cb>14 stopper at th e1i--Cb>14~I
stopper bowl dia not include simulation of reaching into tlie 6owl.
,_ _. _
d. Review of the Air Flow Visualization Studies and the Air Flow Visualization Study
Protocol E3-UTL-RQ-P-0032, entitled, "Dynamic Air Flow Visualization Studies", for
Line ~~Bloc~ used to aseptically fill vials for the U.S. market, revealed that the study
failed to assess air flow while the filling machine was rnnning (dynamic condition).

The fnm management stated the sam e smoke study approach applies to all Bloc~ and Bloc~
aseptic fill lines.
4
3. Qualification of the HVAC system for the Line 1 c1,rc l machine did not demonsb.'ate it can
maintain appropriate air quality for aseptic filling of US marke( CbT<1 and! CbTc4
products.

a. The I Cb>1-41 of the1 Cb>14j occurs in an area that has

been classified Grade C with no overhead HEPA coverage. No NVPC data has been
collected in this area to demonstrate appropriate paiiicle conb.'ol. Smoke studies have not
evaluated whether air flow from this area would allow air to ingress into the Grade A
filling zone.

b. Smoke studies of the Grade A filling zone demonstJ.·ate turbulence near the area where
containers are filled. The smoke studies do not evaluate if air from smTounding ai·eas can
ingress into the filling zone. There has been no dynamic NVPC data of the Grade A

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FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 15 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2 4 20 Parkl a wn Drive, Room 2032 1 /22/2024 - 2/2/2024*

FEJ NUMBER
Rockvi lle, MD 2085 7
3 008461 61 9

NAME ANO Tm E OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Sha s tri, Pre s iden t - Ope r ations

FIRM NAME STREET AOORESS

Eug ia Ph arma Spe c ial itie s Li mited 3 4 To 4 8 Plot No : 4, Unit - Iii; Ts iic
CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLI SHMENT IN SPECTED

Sa ngareddy, Te l a nga n a, 50230 7 I n dia Steri l e Dr ug Ma nufac t u rer

(bTC,
filling zone below the filling!

OBSERVATION 5
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of
its components to meet any of its specifications whether or not the batch has been ah-eady distributed.

1. Investi~ation Re, rt APL-FU4-PNC-22-0255 was opened when media fill batch

[ ::) ~1mL vial), conducted on Line ~ in Block ~ was found to have 124
contammatea units. . These contaminated units were consistent y found in vials located
throughout trays 1 (bTC1 (out of •H4ltotal trays) . The investigation attributed the media fill failure
to a vial breakage that caused spilled media at the stoppering station. Per 01· investigation, the
SQilled media from the broken~ vial also traveled the entire (b)14 foot "(bTC4 mm)Jength of the
r ·~(b)14l conveyer and generated visible spillage under the conveyer at the (b)~ tanks. No
contaminated units were observed until more than 11 hours after the initial vial 6reakage and
media spill. Surface monitoring of the filling line did not detect any contaminants. The
investigation failed to thoroughly assess any other potential sources of the microbial
contamination.

Similar occunences were observed during commercial batches. Vial breakage at the stoppering
station was obse1ved during I (b>1ilj Injection bat:f h t"JT1 on Januaiy 20, 2024.
1 4
SQillage at this same location under the conveyer at the (b)( j tanks were obse1ved during
(b)C
1 Injection batche (bT(1 (Januaiy 18, 2024) and I (bT(1 (Janua1y 20,
2024).

2. Investigation APL-FU4-PNC-23-0499 was ooened due to the reject rate!~ f~(b11 l % during 100%
:=::i
ana1yzer ana1ys1•s of :~ '
4
(b)(-0j 1n·Jecbon
• • 1s bateh
(bT(lj via
exceeding the Ir ct , limit O T )( ]%. No assignable cause was 1aenbfied, but the
\ UJ\~ j

probable caused identified {l,H<1 stoppers for some vials following the [(1:5) (21-) I and

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X 12SS(16

Anastas ia M Shie l d s , I nve s tig ato r

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 16 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVI CES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2 4 20 Parkl a wn Drive, Room 2032 1 /22/2024 - 2/2/2024*

Rockvi lle, MD 2085 7 FEJ NUMBER
3 008461 61 9

NAME ANO Tm E OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Sha s tri, Pre s iden t - Ope r ations

FIRM NAME STREET AOORESS

Eugia Pharma Spe c ial itie s Li mited 3 4 To 48 Plot No : 4, Unit - Iii; Ts iic
CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLI SHMENT IN SPECTED

Sa ngareddy, Te l a nga n a, 50230 7 I ndia Steri l e Dr ug Ma nufac t u rer

CAPA APL-FU4-PNC-23-0499-CAPA-l was opened to monitor the next 30 batches. During

this monitoring, additional batches exceeded the C4J% rej_ect limit for lbT<4l analyzer
were identified including US batches lb>(' 1n·ection batch '"" lb>14 %),
4 4
(6) (~) Injection batch lh>< lh>< %), and D 4 Injection batch

----·- '""~ '""~%). The CAPA did not identify any assignable cause. There were no identified
con ectlve actions or preventive actions implemented.
0
The invj tiga~ ~ was not extended to the other US market '" products manufactured in
the same lh>1" that do not receive IOO% i - -lb1 <<1J analysis. There was no investigation
of whether via s from these 1,)atches similarly lackappropriate lb>1il due to potential
ingress of lb)C4J that could negatively impact the quality and stabili of the
product. The followin US market W(l • roducts are not I 00% anal zed for lb1141
(6) ~ Injection, b 4) Injection '"""
UJl'IJinjection (b 4) Injection (b) (4 Injection, b 4 Injection,
b 4 Injection, ana b 4 lnJect1on.

3. OOS inve_stigation 4OOS230142 was opened for wc1 Injection batch lbT<4l at
4
th e (b)( 1 b·1· d. • h
ong te1m sta 11ty con 1bons, w en _..,,...""""'____ lbT] ha a resu1t
d
of '""~'% compared to a specification of not more tfian r >, %. Tfie OOS was mva idated based
on a literature review that said the impurity could be fo1m ed under lb>14l The conclusion
stated the sample may be OOS because of exposure to the environment during sample
preparation. The investigation found no abno1malities in sample preparation and no hypothesis
testing was perfo1med to dete1mine if environmental exposure could generate an increase in this
impurity. The stability data showed an increasing trend from lb)~ % at time of release to
4
lb>1 % at the 12-month timepoint tested prior to the OOS result.

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Anastas ia M Shie l d s , I nve s tig ato r

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 17 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVI CES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2 4 20 Parkl awn Drive, Room 2032 1 /22/202 4 - 2/2/202 4*

Rockvi lle, MD 2085 7 FEJ NUMBER
3 008 4 61 61 9

NAME ANO Tm E OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shas tri, Pre s iden t - Operat i ons

F IRM NAME STREET AOORESS

Eug ia Pharma Spe c ial itie s Li mited 3 4 To 48 Plot No : 4, Unit - Iii; Ts iic
CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT IN SPECTED

Sa ngareddy, Te l a nga n a, 50230 7 I ndia Steri l e Dr ug Ma nufac t u rer

This stated root cause was not extended to investigate commercial manufacturing, to evaluate
how long vials that have been filled, but not stoppered, can remain on the line when there are line
stoppages.

4. Procedure E3-QC-CI-GEN-0009 "Handling of Out of Trends" was not followed to open

investigations based on stability testing results.

a. (bY{il batch W(l (US market) exceeded the changes from one time oint
--,-----,,-- (b)1 4l
to the n~xt that requires an OOT investigations for the three month time~oint
(b)C4l six month time oint (b><-l nine month time oint
- -i-
twe ve - month trmepomt
. . ___ (b><4
an d expiration
. . date ..._________ (b><4

investigations were openea.

b. The on-going stability study (6 months completed of the rocess validation batches for
OC b 4 !Injection rn~mg/vial, -...-"""""' (bj and (b,{il
does not oilow tlie expected trencHor assay y HPLC) m compan son w1tfi prev10us
stability studies of the same product. Per your procedure outlined in SOP EP3-QC-SOP-
032, OOT investi ations are reguired for results which suggest the potential for OOS
results to occur (b)<<ll within the sam~ stability study. The followrn,
4 4
data was obtained for the first 6-months of the (b)( shelf life (Specification 1{
(bY{<I %) and no OOT investigations have been opened:

Batch (bTC4l the assay results are

(6M) -----
Batch ~~~~, the assay results are (b11 41 % (initial), 11 41
(b % (3M), and 11 41
(b % (6M)
Batch ~ the assay results are (b)( 0, 1'.o cm1
· .ba. 1), (bH % (3M) and (bH4l% (6M)

5. OOS investigation 04OOS220099, was opened when fmished product test for (b)"'"t4l (by (b)C4l for

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An a s tas ia M Shie l d s , I nve s tig ato r

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 18 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVI CES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2 4 2 0 Parklawn Drive, Room 2 032 1 /22/2024 - 2/2/2024*

FEJ NUMBER
Rockville, MD 20857
300 8 461 61 9

NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shastri, President - Operatio ns

FIRM NAME STREET AOORESS

Eugia Pharma Specialities Limited 34 To 48 Plot No : 4, Unit - Iii; Tsiic

CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Sangareddy, Telangana, 502307 India Sterile Drug Manufacturer

(b114l . . (b1 . #. (b)14tj WCl

I InJect10n c41mg/Vial, Batch
j was found to be
4
% on test
sample #2 (detennination-2 of 2), against the specification of not more than ~%. As paii of
your OOS procedure, HO-CQC-SOP-029-00, fresh samples were used and two additional
r
investigational tests perfoimed. The investigational test results found test samr lej #l to be OOS
• h a resu1t (bT(4lo/co. A secon d mvesbgabon
wit • • • test was nm wit• h a resu1t of (bT( o/co. Per your
investigation, the OOS result was deteimined to be invalid when these test results were averaged
together to obtain a passing result of (b)l %. Your fom does not have a procedure that defmes
when averages are acceptable.

6. There have been four rejected batches of l (bT(L iniection (US market) for exceeding the
limit for individual unknown implr ty including I (b,C.Jj (May 2023), I (b)1.J1 (May 2023),
I C4
(Febmaiy 2020), and (bTCl~
(Febmaiy 2020). The most probable cause m •
the
2020 fai~ ure investigation included aispensed API that was exposed to room temperature for a
prolonged period prior to compounding. A similai· root cause was identified in the 2023 failure
investigations.

market batches I
(bT(4l
) and (br(4, r
Other batches have similar total time out of refrigeration as the rejected batches, including US
1
but these were not considered in the
investigation.

Investigations have not collected data to demonsti·ate this is the root cause and deteimine an
appropriate limit for the maximum amount of time out of refrigeration before compounding. No
time limits have been established in the batch records.

7. 04OOS220227 was initiated on December 1, 2022 for I (bTC1 Injection, USP

I C6ff1 m~,,,l]mr, l
(bf~ Vial) batch L
ll>Hl Osmolality OOS result. The obtained
result was (b)14 mOsmol7lcg and tlie release specilicabon was between (bTC4l and (bTC4l mOsmol/kg.
Phase I investigation identified no obvious laboratoiy enors. Phase Ila manufacturing

EMPLOYEE($) SIGNATURE DATE lSSUEO

SEE REVERSE Justin A Boyd, Investigator 2/2/2024

OF THIS PAGE Eileen A Liu, Investigator - Dedicated Drug .........
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Anastasia M Shields, Investigator

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 19 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2 4 2 0 Parklawn Drive, Room 2 032 1 /22/2024 - 2/2/2024*

FEJ NUMBER
Rockville, MD 20857
300 8 461 61 9

NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shastri, President - Operatio ns

F IRM NAME STREET AOORESS

Eugia Pharma Specialities Limited 34 To 48 Plot No : 4, Unit - Iii; Tsiic

CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Sangareddy, Telangana, 502307 India Sterile Drug Manufacturer

investigation found all stages under the state of control. Phase Ilb hypothesis testing did not
identify any assignable root cause. The investigation suspected the root cause might be due to
improper clej ning of( ample l. 11
(b 1
hence recommended re-testing. However, the suspicion of
di1iy sample (b)C4l being tlie root cause was not confnmed~~othesis analysis. To note, a

total of 31 samples were tested on the same date. Only Bate~ {li).J
was found OOS. Your
fnm's investigation lacked scientific justification or confnming info1mation to suppoli the
conclusion that the use of di1iy sample l (b>1il1 was the root cause thus allow to re-test.

Nonetheless, on Januaiy 10, 2023, a new sample was used for the re-test analysis. Results
obtained from the re-test found meeting specification and the original OOS result was
invalidated. B~;&rtc
h {lir(41~
fg. 11/2022, Exp. I i umts
(bT(4) • )
was d'1spatch ed to th e
U.S. mai·ket o (6) (4)

8. 04OOS220186 was initiated on September 29, 2022, for

I (6)7(1
solution USP {lir(44j
batch
(b)(4
,b,
(bT"'l and

·i 3 months long te1m

condition stability stm~i OOS result for Paiiiculate Matter by light obscuration method. The
obtained result was ~□aiiicles/mL and the release specification was not more than ~
paiiicles/mL (for > or= < ~Lm). Phase Ia investigation identified no obvious laborato1y eITors.
Re-measurement of the on gmal samples was also OOS. Phase Th investigation found a wet glass
measuring cylinder was the probable root cause. During the Phase Th hypothesis analysis, higher
but still within acceptance pa1iicle counts were obtained when a wet glass measuring cylinder
was used. Based on the hypothesis outcome, the usage of wet measuring cylinder was identified
as the root cause. The Phase Ila manufacturing investigation yielded no discrepancies. On
October 8, 2022, re-test analysis was initiated and found result within acceptance. The original
OOS result was thus invalidated. Your fnm 's investigation was inadequate in that the Phase Th
hypothesis outcome only suggested but did not confnm the wet glass cylinder was the defmitive
root cause. Nonetheless, the original OOS result was invalidated. A different sample was used
1141
for re-test and the result was found within acceptance. Batch I (b ·~ (Mfg. 06/2022, Exp.

I 11
(b 1
units) was dispatched to the U.S. market on[(b ) 4) .

EMPLOYEE($) SIGNATURE DATE lSSUEO

SEE REVERSE Justin A Boyd, Investigator 2/2/2024

OF THIS PAGE Eileen A Liu, Investigator - Dedicated Drug .........
~ - Dedlc-.:IOT.g
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=~~
Cadre X 12SS(16

Anastasia M Shields, Investigator

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 20 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVI CES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2420 Parklawn Drive, Room 2032 1 /22/2024 - 2/2/2024*

Rockville, MD 20857 FEJ NUMBER
3008461 61 9

NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shastri, President - Operations

FIRM NAME STREET AOORESS

Eugia Pharma Specialities Limited 34 To 48 Plot No : 4, Unit - Iii; Tsiic

CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Sangareddy, Telangana, 502307 India Sterile Drug Manufacturer

OBSERVATION 6
Your fnm failed to establish adequate written procedures for production and process controls designed
to assure that the diug products have the identity, strength, purity, and quality that they are purported or
represented to possess.

I .Process perfo1mance qualification studies for the US market products do not include evaluation of
intra-batch or inter-batch variability. Without acceptance criteria for variability, process
perfo1mance qualification studies were approved without evaluating sources of potential
variation. For example:

i.During assay testing of the filled vials (specification (bTC-0%), the 6) (4

4
samples of batch (b)1 were OOS with a result of (bH4 % . The associated
OOS investigation identified no root cause.

Batcb'._ _ _(bTC4l showed intra-batch variability with the (15) (21-) sample at
(b)14 % and the(b)C sample being (b)14 %.

There appeared to inter-batch variability with batches t"JT1 having higher

assay values W(l %~ %) compared to batch _ _ _ _ _(b_f"_ %~ % ).

ii.The finished ~roduct testing for (b)l content varied from (b)C4l%
(b)1il % _ _ _ __.
(bTC4l compared to a spec1ficat10n
· · of not more than □ %.

(b)14l . . . d fi (b) (410 I'. (bT(,

1mpun ty van e ·o~ ,o to
____(b_H: -c-o_m_p_ai_·e_d,,.to a specification of not more than r )( ]%.
4

EMPLOYEE($) SIGNATURE DATE lSSUEO

SEE REVERSE Justin A Boyd, Investigator 2/2/2024

OF THIS PAGE Eileen A Liu, Investigator - Dedicated Drug
Cadre
Anastasia M Shields, Investigator

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 21 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2 4 20 Parklawn Drive, Room 20 3 2 1/22 / 2 0 24 - 2 / 2 / 2 0 24*

FEJ NUMBER
Rockville, MD 20 857
3 008 461 61 9

NAME ANO Tm E OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shastri, President - Operatio ns

FIRM NAME STREET AOORESS

Eugia Pharma Sp ecialities Limited 34 To 48 Plo t No : 4, Unit - Iii; Tsiic

CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Sangareddy, Telangana, 5 02 3 0 7 India Sterile Drug Manufacturer

b.Dc process valisJation ofOC£) ( 4) _IInjection (b,{4 mg for Block ~ Assay testing
(bWjwas not talcen from aitferent points to allow for evaluation of intra-
batch variability. Sampling was done randomly with a single reported result for each _
batch. These assay results ~ peared to show inter-batch variability with batch I (b)C,
4
at ~ % and batch I
4
<)with a result of (b)1 %, compared to a specification of
(b)(4 ¾ (b,{4 ¾
0 0.

2.Per process validation protocol E3-PPQ-P-0131 and repo1t E3-PP9,:g.-_9148 and the prior protocol
FU4-SIAT_-PQP-006 and report FU4-PPQ-R-0021 for (b)C, Injection,
4
(b,{4 m~ ~mL, your fnm failed to validate theL (b)( allowable time limit for line stoppage

dunng via 1lling where filled, open vials are exposed to the sun ounding air and the affect this
exposure has on product degradation.

The following are examples where the line wa~ stopped with exposed unstoppered vials of
b) (4 !Injection, batch, ~ (b1(4j (US market):

(bT<i conveyer Closed.

'""l IfQA person went towards filling HMI side.
(bT'4} IPQA plates taken.

OBSERVATION 7
Appropriate controls are not exercised over computers or related systems to assure that changes in
master production and control records or other records are instituted only by authorized personnel.

1. There are no controls to prevent operators from changing the date and time on the Climet non-
viable particle count equipment. Operators stated they had changed the date and time to back
date printouts. Additionally, the instIUillent is capable of storing and backing-up electi·onic data,

EMPLOYEE($) SIGNATURE DATE lSSUEO

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OF THIS PAGE Eileen A Liu, Investigato r - Dedicated Dru g .........
~ - Dedlc-.:IOT.g

Cadre
°""
=~~
X 12SS(16

Anastasia M Shields, Investigato r

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 22 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2 4 2 0 Parklawn Drive, Room 2 032 1 /22/2024 - 2/2/2024*

Rockville, MD 20857 FEJ NUMBER

300 8 461 61 9

NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shastri, President - Operatio ns

F IRM NAME STREET AOORESS

Eugia Pharma Specialities Limited 34 To 48 Plot No : 4, Unit - Iii; Tsiic

CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Sangareddy, Telangana, 502307 India Sterile Drug Manufacturer

but the function is not used.

2. CAPA APL-FU4-PNC-23-1 089-CAPA-4 was opened August 17, 2023, following a oroduct non-
confonnance investigation that identified the wrong date on printouts fro b (4 I for in
process checks. The investigation identified thJ.(6) (4) I and dissolved oxygen meters lacked
controls to prevent operators from changing the time and date. The CAPA identified the need to
upgrade the instmments to improve data security. But no upgrades have been completed as of
Febmaiy 1, 2024, and no interim controls were implemented.

Additionally, the Oxi 73 10 Dissolved Oxygen Meter allows automatic saving of electronic data
that can be backed up to a USB or transfe1Ted through a connected computer, but these
capabilities ai·e not being used.

OBSERVATION 8
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational
unit.

I.Change Control, APL-FU4-CC-21-0673 for.I (bT(l~ InJecbon,

. . (b) (-0 mg ( b ,mL
{il~
_
□
. 1 ented visual inspection for color change, mtiie filed and sealea vials,
4
Cb>< 1
sterilization. As paii ofrecall investigation APLUnit 04/INV/651/20-00, for this saine
product, which included color change from cleai· to [(6 ) (4) I (indicative ofl ;-:J
degradation), you perfo1med a review of your control sample visual mspection results. Per t 1s
review, color change was not observed in any vials until the Cb,: ) Yet, based on this review,
11
1
you chose1 (b as your inspection time point when reviewmg the batch for color change prior
to batch release.

The following are examples of complaints subinitted for color change from clear to E_)'j
[(b) (4 !which were received following the implement of the aforementioned cfiange

EMPLOYEE($) SIGNATURE DATE lSSUEO

SEE REVERSE Justin A Boyd, Investigator 2/2/2024

OF THIS PAGE Eileen A Liu, Investigator - Dedicated Drug .........
~ - Dedlc-.:IOT.g
°""
=~~
Cadre X 12SS(16

Anastasia M Shields, Investigator

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 23 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVI CES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2 4 2 0 Parklawn Drive, Room 2 032 1 /22/2024 - 2/2/2024*

FEJ NUMBER
Rockville, MD 20857
300 8 461 61 9

NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shastri, President - Operatio ns

F IRM NAME STREET AOORESS

Eugia Pharma Specialities Limited 34 To 48 Plot No : 4, Unit - Iii; Tsiic

CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Sangareddy, Telangana, 502307 India Sterile Drug Manufacturer

control:

a.APL/FU4/2022-USA-PCM-00141
b.APL/FU4/2022-USA-PCM-00 152
c.APL/FU4/2022-USA-PCM-00158

2.Prior to June 30, 2022, CCTV recording review for aseptic manufacturing operations was pa1t of
the batch record review and disposition decision for each batch. Change control APL-FU4-CC-
22-0128 eliminated this review for each batch with no documented justification, evaluation of
historical data, or assessment of the impact of this change.

Change control CCP-EP-CQA-23-0023 fmther implemented changes to the CCTV recording

process by changing procedure CQA-SOP-GEN-026 on May 4, 2023, that reduced the amount of
• v1·deo record.mgs o f product1•on activities
time • • • 1•s saved to pemnt • fI·om.
• review (b1141i to r
4
,Y-(' 1
The justification stated: "For better compliance", but no explanation could be provided to explain
how this change would result in better compliance.

OBSERVATION 9
Laborato1y conti·ols do not include the establishment of scientifically sound and appropriate test
procedures designed to assure that diug products confo1m to appropriate standards of identity, strength,
quality and purity.

Your fnm ' s sterility test method suitability and routine test method for the release ofl (bTC<ll diug

product (DP) is deficient in that the products are not afjropriately l

4
c1JJC for testmg. Examples l
include but are not limited to the followings I (b) j products:

1. [6) (~) !Injection, ~1 mg/vial is l (b)(,

EMPLOYEE($) SIGNATURE DATE lSSUEO

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OF THIS PAGE Eileen A Liu, Investigator - Dedicated Drug .........
~ - Dedlc-.:IOT.g
°""
Cadre =~~
X 12SS(16

Anastasia M Shields, Investigator

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 24 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVI CES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

1 2 4 20 Parklawn Drive, Room 2032 1/22/2024- 2/2/2024*

FEJ NUMBER
Rockville, MD 20857
3008461619

NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shastri, President - Operations

FIRM NAME STREET AOORESS

Eugia Pharma Specialities Limited 34 To 48 Plot No : 4, Unit - Iii; Tsiic

CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Sangareddy, Telangana, 502307 India Sterile Drug Manufacturer

instead ofl (b>144~as m • the fimis

• dicate d m • h ed ~roduct
(bTC,
Ce1iificate of Analvsis (COA). Per COAi
(b)1,

2. (6) (~) . .
In1ect1on, {lir(4) Illg/via . I
. 11s (bTC1 instead of (bT~
(lj4)
4 (b)(4
(b)1 ~as indicated in the COA. Per COA i
(b)14j

3. b)(4) IIniection, (bT(l g/vial is) (b)C4l instead

4 (bT(,
of (b)( i as indicated in the COA. Per COA i
(b)1,

Your fnm lacked justification for using I

11
(b 1
other than the ones that have been validated
through the manufacturing process an d represents patient use. You do not have studies to show that
{lir(44j • • (6)~(4 1 1(6)~('41
1s a smtable that can adequately
(b)(4·i wit
• h'm a val'da
1 ted time
• fi·ame.

I (bH4j was used in the original sterility met!iod suitability.

However, w1tliout lmowmg its abihty to comRlete1
4
(b11 the respective! 1 (b1(4j diug product, one

cannot rnle out the possibility that a lower {li c product concenb'ation instead of the intended
concentration was tested for inhibition of microorganisms.

*DATES OF INSPECTION
1/22/2024(Mon), 1/23/2024(Tue), 1/24/2024(Wed), 1/25/2024(Thu), 1/29/2024(Mon), 1/30/2024(Tue),
1/31/2024(Wed), 2/01/2024(Thu), 2/02/2024(Fri)

EMPLOYEE($) SIGNATURE DATE lSSUEO

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OF THIS PAGE Eileen A Liu, Investigator - Dedicated Drug .........
~ - Dedlc-.:IOT.g
°""
=~~
Cadre X 12SS(16

Anastasia M Shields, Investigator

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 25 of26 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVI CES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF INSPECTION

12420 Parklawn Drive, Room 2032 1 /22/2024 - 2/2/2024*

Rockville, MD 20857 FEJ NUMBER
3008461 61 9

NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT ISSUED

Atul Shastri, President - Operations

F IRM NAME STREET AOORESS

Eugia Pharma Specialities Limited 34 To 48 Plot No : 4, Unit - Iii; Tsiic

C ITY. STATE. Z IP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Sangareddy, Telangana, 502307 India Sterile Drug Manufacturer

.bstin.A ~ Anastasia M Shields

X = y: 2000358686
o... s;gned: 02-02-202<1 12:55:54 X
~ere; Anast3sia M. 5-lds -S
Date s;gned: 02-02-202• 12:56:52

APPEARS
THIS WAY
ON
ORIGINAL

EMPLOYEE($) SIGNATURE DATE lSSUEO

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OF THIS PAGE Eileen A Liu, Investigator - Dedicated Drug
Cadre
Anastasia M Shields, Investigator

FORM FDA 483 (09/08) PREVIOUS EDmDN OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 26 of26 PAGES