DEPARTME1'T O f' II E/\LTH AXD lllJMA~ SERVlCES
FOOD A\'D DR l;G ADMfNISTRATION
DeSTRfCT ADORES$ AND PNONE NUMBER
10903 New Hampshire Ave , Bldg 51 , Rm 4225
Silver Sprinqs , MD 20993
(301) 796-3334 fax : (301} 847 - 8738
Industr
01/04/2016 - 01/1 2/2016*
Ft:I NUMBER
3009278506
Information: www . fda . gov/oc/industry
NAME A'fD TlTl£ c,' ~ - 10WHOM REPORT ISSUED
TO:
Uda kurnar Rakibe, Senior Vice President Qualit
Wockhardt Limited
Plot No E 1/1 MIDC Area
CITY, S1'ATE, ZJP OC>De. COl.NTRY
TYPS ESTABUS~ENT INSPECla>
Shendra Aurangabad
431201 ,
'
St eri l e and Non-sterile Finished Dosage
India
Dru
Manufacturer
This document lists o bservations made by the FDA represcntative(s) during the inspection of your facility. They are inspectional
observations, and do not represent a final Agency determination regarding your compliance. Ifyou have an objection regarding an
observation, or have implemented, 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 information 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 WE OBSERVED:
OBSERVATION 1
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.
Specifically during our limited review on January 4 - 12, 2016 of your firm's electronic equipment data
and system audit trails we found the following:
'---A) When reviewing data from the b><4>
tester (Equipment# Pl/EQP/PR2/05 I) used
for testing 1bH4>
of<b><4>
fo lb><4>
testing; we found 22 unreported failing
results. The unreported failing results were from data reviewed from January l, 2015 - January 6,
2016. According to Sen.ior Vice President - Quality, the firm hru;ll>H4> othe ll>H4>
machines
4
which also have unreported failinelbH >
test results.
B) It was observed that data can I was being deleted.
,,.
~ ; . -- - - - - ~6) (4)
I H4 >
files were deleted fro ,uH4 >
__, testers as stated on the
instrument software Audit Trails.
4
a. From Ma 28 2015- January 11, 2016, H4>
tester for thJbH >
4
"bH >
Facility Equipment~# Pl/EQP1F><4 >
had 3 lb><4>
fi·.1e
,.._s_ .....
dele1ed without archiving the run file.
t 6><4>
b. FrOJll-.bU!!USt 6 20 4- January 8, 2016,ll>H4>
tester for the
4
1b>< >
acility Equipment # P l /EQP111b><4 > Y05 l had lb><4 >
fi le_s_ _
deleted without archiving the run file.
c. From June 16 2015- January l l , 2016iib><4>
lbH4>
aci lity Equipment #:-:P""'l,....,/E
= Q""
W,><4 >
deleted without archiving the run file.
d. On March 11 , 2015-January ll,2016 1b><4>
testerforthe
bH4>
Facility Equipment# P l/EQ~
046 had 69 b><4>
files
deleted without archiving the run file.
the
________
------
yos2
1
~~~~~~~~~~~-
EMF'l.OYEE(SJ SIGNATURE
SEE REV ERSE
OF THIS PAGE
l'OR!\f l'DA 4831()9/0I)
DATEISSUEO
Daniel J . Roberts, Investigator
Dipesh K. Shah, Investigator
~SPECTIONAL OBSERVATlONS
01/12/2016
PAGE I OF 7 PAGES
O.EPARTMENT OF HEA LT II AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
0,,.TE{S) OF INSPECTION
10903 New Hampshire Ave,Bldg 51 , Rm 4225
01/04/2016 - 01/12/2016*
Silver Sprinqs , MD
FEINVMBER
(301) 796-3334
Industr
20993
3009278506
Fax : (301) 847-8738
Information : www.fda . gov/oc/industry
NAME /WO Tlll.E ~ INlM[)tJAI. lOWHOM REPORT ISSU£0
TO:
Uda kumar Rakibe , Senior Vice President Qualit
FIRM NAME
STREET ADDRESS
Wock.hardt Limited
Plot No E 1/1 MIDC Area
cnv. S'JATE., ZIP COO£. eot.NTRY
Shendra Aurangabad
431201,
India
Sterile and Non-Sterile Finished Dosage
Drug Manufacturer
2- The computer used for the Falcon temperature monitoring software allowed employees to delete
warehouse temperature results. This computer is located in the warehouse where fmal product,
excipients, and raw materials are stored belowm ° C. Furthermore the software bas no user
access control p rofile class for each employee who uses the software, i.e. administrator and I or
production worker.
C) It was observed that passwords are shared in the fo llowing computers:
1- The administrator password and user name "mentor" for the<b><4>
machines are shared by
4
4
at leas >< >
production an ;(1>>< >
engineering de artment employees. On January 5, 2016,
the mentor user name was used to perfo lb><4>
testing which is a production employee
function. The administrator has the ability to delete, transfer, and other functions of data.
According to Senior Vice President - Quality, the firm halCb><4 > othe 'll>><4>
machines
which also use the administrator password and user name "mentor".
2- The administra~or ssword and user name "Manager" for the<b><4>
p rogram is
4
being shared byl~l employees. This program is used forth1;<b>< >
printer which is
4
Jfinal product packaging.
used to print out barcodes on bundle labels used fol>< >
D) The firm has ,no4.Standard Ooerating_e.rocedures and no recordsare taken when a backup of the data
.1s done on aJl(b)( )
I_
. the ase tic
. rocessm
. area.
testers used m
~~~~~~~~
OBSERVATION 2
Written production and process control procedures are not documented at the time of performance.
Specifically, on January 4, 2016 production related documents were observed from three (3) different
trash points located at the facility.
A) Trash point located outside of th lb><4>
block, we observed the following:
4
test printout results dated January I, 2016 of which two (2) of these
1. Three (3J6>< >
test orintouts ad unreported failing analysis.
4
•me steril'IZ8t1on
. sheet t hat was unaccounted ~1or m
. th e bateh ro d uct1on
. record .
2. 0 n tbH >
5 4
Accordme_tq section 6.4.9 of Operating and Cleaning 0~< >< >
4
tb>< >
SH/PD/308 states, "Attach the 1b><4>
rintli-av
- e~ ·-e-details of cycle parameters
and batch details along with the cycle printout taken on A4 size paper."
4
3. Four (4)<b>< >
ad production timings and miscellaneous data written on them that were
used durmg stenlization process.
B) Trash point located in the scrap yard, we observed the following:
4
1. At least two (2rn >
had production timings written on them along with miscellaneous
DATE lssua>
EMPI.OYEE(S) SIGNA~
SEE REVERSE
OF THIS PAGE
Daniel J . Roberts , Invescigato\~~Q-
Dipesh K. Shah, Investigator
~
l~SPECTIONAL OBSERVATIONS
01/12/2016
PAGF20F7P,<ClES
DEPARTMENT OF HEALTit AND ITTJJ\1'AN SERVICES
FOOD AND DRUG ADMINlSTRATION
DI.STRICT MX>ftEa8 AND P H O N E ~
OA.TI:{#) OF INSPfCT10N
10903 New Hampshire Ave,Bldg 51 , Rm 4225
01/04/2016 - 01/12/2016·
Silver Sprinqs, MD 20993
Fax : (301) 8 47 -8738
(301 ) 796-3334
Industry Information : www.fda.qov/oc/indus try
FOHUM8ER
3009278506
IW'E»ID TIT1..E OFI -TO 11,MOM RS'Oin 1SSUE1>
TO:
Udaykumar Rakibe, Senior Vice President Quality
STRe,...
=T ADORE.$,S
flRMNAME
Wockhardt Limited
Plot No E 1/1 MIDC Area
Q TY, STATE, ~p C00E. COUNTRY
TYPE ESTABU91MENT INSPECTED
Shendra Aurangabad
4312 01,
India
Sterile and Non-Sterile Finished Dosage
Druo Manufaccurer
data that were used during production.
2. Five (5) material use labels used to identify materials were thrown out without defacing the
labels. According to Senior Vice President - Quality labels should be e ither defaced or cut
prior to throwing them out.
C) One (1) bag of unaccounted shredded documents was discovered next to a shredder machine located
inside the microbiology quality control laboratory. The bag of shredded documents included the
following:
controlled documents with official Issued b QA stamps
l. Indistinguishable
.
lb)(4)
2. Signed laboratory worksheets fo
'"'hromogenic combistat
>
, statisttal
analysis
printouts
---iv,
4
4
3.
J
ork reports containing uncontrolled notes abou
ork being performed and
)
schedule planning for the quality contro l testing labora o ry
~n
r)(
OB SERVATION 3
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Specifically, during the inspection we found the fo llowing regarding the environmental monitoring
program for the aseptic processing area:
A) The worst case locations have not been defined for perfonning microbiological surface contact plate
and swab sample routine environmental monitoring in the aseptic processing area used to
manufacture sterile injectable products.
lbH4>
B) The<b><4>
environmental monitoring trend report fol'j
4
>
facility was not completed until lb><4>
LJanuar:y_S 201 6. In addition, missing
environmental monitoring trend data for the,-,' '
cility for thcll>> <4>
J
lb)(4) anct><4>
I was not detected until January 4, 2016.
C) Rationale is not available for the reduced testing locations for viable passive and active a ir sampling
selectfci 4during aseptic filli ng operations. For example for viable passive settle plates, only seven (7)
out o bH >\ota1 settle plate locations are continuously monitored throughout the aseptic filling
operation.
D) On January 4, 2016, during a tour of the microbiology quality control laboratory five (5)
environmental monitoring plates that were read approximately 2 hours prior a <b><4>
I were
discovered dehydrated with shrink.age and cracking. These environmental monitoring plates were
exposed in the production area on December 29, 2015 and correspond to the following locations in
the aseptic processing area:
I
l6n
SEE REVERSE
OF THIS PAGE
FORM FDA 4SJ (0911111)
£MJII.OYEE(SJ S!GHATURE
0,.fE ISSUED
Daniel J . Roberts , Investigato~ 9 Dipesh K. Shah, I nvestigator
01/12/2016
PREVIOUS ED!nON 0BSa.En
lNSP£CTIONAL OBSERVATIONS
PAGEJOF7PAGES
DEPARTMENT OF II FALTII ANO IIU MAN SERVlCF.S
FOOD Af/D DRUG ADMlNISTRATlON
OISTKICT ADDRESS ANO PHONE NUMt,t;R
0 ,._T!(S) f'Y INS?e:CTION
10903 New Hampshire Ave , Bldg 51 , Rm 4225
Silver Sprinqs, MD 20993
(301) 796-3334 E'ax: (301 ) 847- 8738
Industry Information : www . fda . Qov/oc/industry
01/04/2016 - 01/12/2016·
FEJ NJl,UlcR
3009278506
'IAME ANO TITLE OF INOMOUAI. TO WHOM REPORT ISSUED
Uday kumar Rakibe , Senior Vice President Qual ity
TO:
STREET ADORESS
FIRMNMIE
1/l MlDC Area
Wockhardt Limited
Pl01: NOE
CfTY, STATE. ZIP 000E. COUNTltV
TVJ>EliST- -(NSPECT£.o
Shendra Aurangabad
•
•
•
431201 ,
India
(b)(4)
Steri le and Non-Sterile Fini shed Dosage
Drug Manuf acturer
i ocated in Grade A Area
ocated in Grade A Area
Uocated in Grade B Area
(b)~)l
.
located m Grade B Area
)!:u~cated in Grade B (Intermediate Area)
(b)(4)
•
•
OBSERVATION 4
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
Specifically, during the inspection we observed the following practices for products manufactured for
the(b> 141
-1block:
A) Prior to December 31, 2015. documentation demonstrating the checking of in9ividual sterile
garments for defects and stains prior to use in the aseptic processing area did not exist. Prior to this
date, the sterile garments used in the aseptic processing area were not uniquely identified and
traceable to their use in the manufacturing area. Furthermore on January 4, 2016, a sterile used gown
without any unique identifier was observed with loose threads and sticbes that was previously used
in the production area and waiting to be laundered.
lb)(4)
B) On January 7, 2016, a production operator in the Grade B I
) oading
area_.was nbserved with exposed skin below the goggles dunng the manufacture of sterile injectable
(b)(4)
xhib.
b lb)(4)
1
1 1t ate
C) On January 5, 2016. an assistant warehouse employee in the dispensing area was observed with a
4
~d<b><4> during the dispensing operation for sterile injectabl f!6H l
•exhibit batch
f H4J
OBSERVATION 5
Complaint records are deficient in that they do not include the findings of the follow-up .
Specifically, ln the year 2014 and 2015. the firm has received eleven(] 1) complaints for missing
primary bottle labels for finished product bottles labeled using the 1(b> <4>
Jpacking line.
P roduct Compla int MC/ SH/ 15-038 confirmed that a possible reason for the missing primary label was
that unlabeled fallen bottles might have passed through the labelling machine to the next station.
However, this complaint investigation did not provide rationale and evaluate the impact to products in
the market that may be affected by a missing a primary bottle label.
EMP\.OYE£(S) $1GNAT URE
SEE REVERSE
OF THIS PAGE
FORM fDA 433 (09/08)
°"TI: ISSUED
Daniel J . Roberts , Investigator ~
Dipesh K. ShQ.h , Invest i gator
~
PREVllXlS llllll"IOI' Cl8Sa.El"B
INSPECTIONAL OBSERVATIONS
01/12/20 1 6
PAGE•OF7PAGES
DEPARTME1'T OF IJEALTII AND HUM,\N SERVICES
FOOD AND !)RUG ADMINISTRATIO!\
CISTRICT AODRESS A,., ...,.,...E NUlotaER
OATE(S) OF "'5PECTIQH
10903 New Hampshire Ave , Bldg 51 , Rm 4225
Silver Sprinqs , MD 20993
Fax : (301) 8 47-8738
(301) 796-3334
FEINUMBER
01/04/2016 - 01/12/2016~
3009278506
Industry Inforrr.ation : w~w . fda . gov/oc/indus~ry
NAME AHO 11TU, Of' U<!ll\llCUAL TO WHOM REPORT ISSUED
TO:
Udavkumar Rakibe , Senior Vice President Qualitv
STREET AOORE$S
FIRMNAME
Wockhardt Limited
CITY, $TATe. ZIP
Plot No E 1/1 MIDC Area
oooe. COUNT'ftY
TYPE E3TAaUSttME:Nf INSPECTE D
Shendra Aurangabad
4 31201,
India
Sterile and Non-Sterile Finished Dosage
Drug Manufacturer
OBSERVATION 6
Routine checking of mechanical equipment is not performed according to a written program designed to assure proper
perfonnance.
Specifically, In the year 2014 and 2015, the firm has received eleven (11) complaints for missing
primary bottle labels for finished product bottles labeled using the<bH4>
Jlabel packing
line. An example of one of the probable root causes for these complaints of missing primary bottle Labels
included fallen bottles might have passed through labelling machine to next station which was
unlabeled.
Corrective and Preventative Actions were initiated under CAP A No. CAPNSH/14/176, CAPA/SH/15082, and CAPA/SH/15- 127 to address missing primary bottle labels for finished product bottles labeled
using the(b><4 >
~
l packing line. The corrections included provisions for fine setting
adjustments to th lbH4>
sensor on the packing line to preclude unlabeled fallen bottles to pass
through the packing line to the next station. However, the effectiveness of the implemented correction
wasn't evaluated and routine challenge tests perfonned on thelbJ<4>
I label packing line do
not include testing for fallen bottles_ In addition, fallen bottles were not evaluated in the equipment
qualification for the(b)(4)
I label packing line.
OBSERVATION 7
Procedures describing the warehousing of drug products are not followed.
SpecificaUy, on January 4, 2016 we observed in-process and raw materials were not labeled or stored
properly in the firm's warehouse cold storage area.
A) Rejected Batclf>H4>
Jwas stored in the Approved material area
instead of rejected material area as required by firm's Standard Operating Procedure (SOP)
SH/WH/004; Handling and Disposal of Rejected Raw/Packaging Materials and Finished Goods.
Section 6.3 of Standard Operating Procedure (SOP) SH/WH/004 states, "The rejected material shall
be shifted to Rejection area, which shall be under lock and key."
4
B) "bH >
~ atches(l>H4 >
JandlbH4>
I Batches
4
4
lbH >
an <bH >
were without Expiration labels as required by firm's Standard Operating
Procedure SH/WH/022; Handling of Expired Materials. Section 6.3 of Standard Operating
Procedure (SOP) SH/ WH/022 states, "Expired Material label shall be pasted in such a way that
portion of Approved label shall covered completely."
SEE REVERSE
OF THIS PAGE
FORM fDI, 483 (o,/Ol'I
EMPLOYEE(SJ SIGNl.TURe
OATE1SSUED
Daniel J . Roberts, Investigator ~ ~
Dipesh K. Shah, Investigator ~
01/12/2016
PRJ,-Yl(llJS EOM'ION Oll&l.EfE
INSPECTIONAL OBSF.RVATIONS
p1,(i? S OF 1 PACES
DEPARTMENT OF HEAL.TU ANO HUMAN SERVICES
FOOD AND DRUG AOMJNlSTRA TION
Ol$TRICT -.SS NO PKlNE NUMIE/1
DAl'otS) Of' INSP!;CTIQH
10903 New Hampshire Ave,Bldg 51,Rro 4225
Silver Sprinqs , MD 20993
(301) 796-3334 Fax : (301) 847-8738
FBNUMSER
01/04/2016 - 01/12/2016*
3009278506
Industry Information : www.fda .gov/oc/industry
HMIEAo;!)TlnEOf INlllVll1W. TOIM'«>MREi'ORJ ISSUU>
TO:
Udavkumar Rakibe, Senior Vice President Quality
STREET A!JORESS
FIRM NAME
Wockhardt Limited
Plot No E 1/1 MIDC Area
CITY. STATt. of> C00E. COUNTRY
TYPE ESTASUSKMEHT INSPECTED
Shendra Aurangabad
431201,
India
Sterile and Non-Sterile Finished Dosage
Drug Manufacturer
t6)(4)
J an (bH4>
'IP/USP/Ph Eur Batches;!b><4>
C) i
I
were without Approval labels as required by firm's Standard Operating Procedure SH/QC/008;
Testing, Release and Rejection of Material. Section 6.17 of Standard Operating Procedure (SOP)
SI-l/QC/008 states, "Affix 'APPROVED/REJECTED' labels on the yellow portion of the "ON
TES
department."
4 " labels pasted b) tarehouse
nl>< >
sPr! <4>
DBatch((b><4>
I was stored alongside approved
materials. That atch should have been stored in Finished Product and Raw Material warehouse
instead of tbe cold storage area as required by firm's Standard Operating Procedure SH/WH/001;
Receipt and Storage of Raw Materials and Packaging Material. Section 6.34 of Standard Operating
Procedure (SOP) SH/WH/001 states, ·'Shift the material to the storage area." According General
J USP ((bH4>
J) Batch:
Manager - Manufacturing stated tha(<bH4>
4
~bH >
is supoosed to be stored in Finished Product and Raw Material warehouse.
OBSERVATION 8
Employees engaged in the packing of a drug product lack the training required to perform their assigned functions.
f(bJ(4)
Sterile injec~J11 drugJ)roducts are filled into
different types of clear and amber glass vials ranging in
capacity frorr:<4> I t lbH4> l. However, personnel performing the Jina! visual inspection of the finished
41
product vials are only qualified for visual inspection using the!bH l clear glass vial type.
In addition, there is no qualification program for operators in the production area performing visual
inspection of unfilled vials prior to use in sterile manufactur ing. Furthermore, these operators
performing the visual inspection of unfilled vials are only provided pictorial representation references of
cracked and gross viaJ defects.
OBSERVATION 9
Equipment used in the manufacture, processing, packing or holding of drug products is not suitably located to facilitate
operations for its intended use.
Specifically, throughout the manufacturing areas the mobile temperature and humidity monitoring
locations are not defined. The mobile temperature and humidity monitoring device can be placed
anywhere in rooms within the manufacturing area. For example, mobile temperature and humidity
! Area, PR2-003 on an{l>H4>
equipment is located in the<bH4>
processing equipment. The firm's Standard Operating Procedure Environmental monitoring of Clean
and Aseptic Area for Change Pressure, Temperature and RH; SH/PD/066 doesn't state where to place
l
SEE REVERSE
OF THIS PAGE
FORl\l f'DA 43J C09/08)
EMPU>YU(S) SIGNATURE
OATEISSUED
Daniel J . Roberts, Investigator ~
Dipesh I< . Shah, Investi gator O,t
01/12/2016
J"KE"nous. fl>l'nONQfJ:,Ol.£1'!
lNSPECTIONAL OBSERVATIONS
PAOE60rUA<ZS
DEPARTM£!\T OF llEALTR AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
OATE(S)Of INSPECTION
DISTRICT AOOftESS ANO PHONE NUMBER
10903 New Hampshire Ave , Bldg 51 , Rrn 4225
01/04/2016 - 01/12/2016*
Silver Sprin qs, MD
fl:.INUMBER
20993
3009278506
Fa x: (301) 847 - 8738
(301) 796-3334
Industry Information : www . fda .gov/oc/industry
TO:
Udaykumar Rakibe , Senior Vice President Qualitv
ARM NAME
STREET ADDRESS
Wockhardt Limited
Plot No E 1/1 MI DC Area
CITY. STATE. ZJP COOll, COUNTRY
TYPE ESTASUSHMENT I-TEO
Shendra Aurangab ad
431201 ,
I ndi a
Sterile and Non-St erile Finished Dosage
Druq Manufacture r
mobile temperature and humidity moni1oring devices.
* DATES OF rNSPECTION:
Ol /0412016(Mon). Ol /05/2016(Tue), Ol/06/2016(Wed), OI/07nOJ6{Thu), OJ/08/2016(Fri), Ol/0912016($at), 01 / 1 l/20J6(Mon),
Ol / 12/2016(Tuc)
ClATE ISSUED
ENPI.OYl;l;(S) SIGNATURE
SEE REVERSE
OF THIS PAGE
f'Okl\l FDA "8J (09/08\
Daniel J . Roberts , Investigat or ~ ~
Dipesh K. Shah , Investigator
~
LNSPECTIONAL OBSERVATIO!';$
01/12/2016
PAO!l 70F? PAGES