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Apicore 483

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39 views2 pages

Apicore 483

Linkdin

Uploaded by

Gajanan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION


DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION

12 4 20 Parklawn Drive, Room 2032 4 /2 7 /2023 - 5 / 5 /2023 *


Rockville, MD 2085 7 FEJNUMBER

3006767695

NAME AND TITLE OF INOMOUAL TO WHOM REPORT ISSUED

Jayaraman Kannappan, Chief Execut ive Officer


F IRM NAME STREET ADDRESS

Apicore Pharmaceut icals Privat e Lt d Block No 252 - 253 , Village - Dhobikuva,


Opposit e Jain I rrigat ion
CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Vadodara, Gujarat , 391440 India Manufact urer

This document lists observations made by the FDA representative(s) during the inspection ofyour facility. They are inspectional
observations, and do not represent a final Agency detemiination regarding your compliance. If you 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) during the inspection or submit this infonnation to FDA at the address above. If you have any
questions, please contact FDA at the phone number and address above.

DURING AN INSPECTION OF YOUR FIRM I OBSERVED:


OBSERVATION 1
Procedures designed to prevent microbiological contamination of diug products pmpo1ting to be sterile
did not include adequate validation of the aseptic process.

Specifically,

A Your fnm manufactures~~6) (4)] batches of sterile (4) Ko)


I USP, APL Your fnm
calculated that one batch of b) (4) IUSP API can be filled intc{(6) (4~ i(6)(4~ di11g
product vials. Media fill study # MF/CPMD/22/04/01, conducted in May 2021 and simulating
I
the manufacture of sterile [lb) (4) IAPI, failed due to recovering I>) <4 JcFU for the
[(o) (4) !simulation, and LJCFU for the l(D) (4) !simulation (DV/22/046). Spore fo1ming
bacteria such as Basileus subtilis, Basileus pumilus, Bacillus oceanisediminis, and Basileus
megaterium, were isolated from the recovered CFUs. Instead of perfo1ming re-validation via
three consecutive media fills, your fnm perfo1med only one repeat media fill.

B. Your fnm uses disinfectants to disinfect your facility and equipment, including surfaces that
come into contact with the sterile APis manufactured by your fnm. Review of your disinfectant
efficacy study (Protocol #s ACP-22-015-00) showed that the study was perfo1med by pipetting
>~ L of the test culture on the coupon and allowing it to diy , followed by pipetting about >J14 LL
of the disinfectant over the di·ied culture. This method of disinfecting is different than your
routine disinfecting procedure (APV-SOP-MFG253) wherein the disinfectant is spread using a

EMPLOYEE(S) SIGNATURE DATE ISSUED

SEE REVERSE Bij o y Panicker, I nvest igat o r 5 / 5 /2023


OF THIS PAGE 8 Pa'IICke<
2001996716

X ':.r-•~2023

FORM FDA ~83 (09/08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIONS PAGE I of2 PAGES
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION

1 2 4 20 Parklawn Drive, Room 2032 4 /27/2023 - 5/5/2023*


FEJNUMBER
Rockville, MD 20857
3006767695

NAME AND TITLE OF INOMOUAL TO WHOM REPORT ISSUED

Jayaraman Kannappan, Chief Executive Office r


F IRM NAME STREET ADDRESS

Apicore Pharmaceuticals Private Ltd Block No 252 - 253 , Village - Dhobikuva ,


Opposite Jain Irrigation
C ITY. STATE. Z IP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Vadodara, Gujarat, 391 44 0 I ndia Manufacturer

mop or wiped using a lint free cloth.

OBSERVATION 2
Routine calibration of electronic equipment is not perfo1med according to a written program designed to
assure proper perfo1mance.

Specifically,

Analytical balance QCE # 684 with a weight range of 20 mg to 200 g is used in your film 's QC
chemistry laborato1y to weigh test samples. Your fnm 's~I:>) (4 );verification of this balance includes only
50 mg to 200 g weight range, and does not include the lower weight range of 20 mg to 50 mg.

*DATES OF INSPECTION
4/27/2023(Thu), 4/28/2023(Fri), 5/0l/2023(Mon), 5/02/2023(Tue), 5/03/2023(Wed), 5/04/2023(Thu),
5/05/2023(Fri)

EMPLOYEE(S) SIGNATURE DATE ISSU ED

SEE REVERSE Bij oy Panicke r, I nvestigat o r 5/5/2023


OF THIS PAGE 8 Pa'IICke<
2001996716

X ':.r-•~2023

FORM FDA ~83 (09/08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIONS PAGE 2 of2 PAGES

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