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Dr. Reddy's Laboratories Limited CTO Unit VI Srikakulam, India 01-20

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Dr. Reddy's Laboratories Limited CTO Unit VI Srikakulam, India 01-20 DEPARTMENT OF HEALTH AND HUMAN SE RVICES FOOD AND DR UG ADMINISTRATION DISTRICT AOORESS AHO PHONE NU"81!R OllTE(SJOf "'SPECTION 12420 Parklawn Drive, Room 2032 01/20/2020-01/28/2020 Rockville, MD 20857 FEINUM8ER 3002949085 ORAPHARMinternational483respo111::>e1::> @fdc1 . hh1::>.yov NNoE lffJ fillE Of INDMOUAl TO wtlO'A REPORT ISSU6D Mr . Arun Gupta, Vice President & Location Head FIRMIWE ST·-··--·- Dr. Reddy's Laboratories Limited CTO APIIC I ndustrial Estate, Pydibhimavarama Unit VI (Village) CITY, STATE. ZP CODE, COUNTRY TYPE EST A8USHMt Nf IN"""CttO Srikakulam District, Andhra Pradesh, API Manufacturer India This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. If you 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 Process Validation is not performed adequately for manufactured products at the facility. 11 1 Specifically, your process validation fortti ' • s inadequate because your firm has (b)<•> Out of Specification (OOS) results from December 26, 2017 - December 9, 2019 for manufacturing of commercial batches. The batches have OOS's for Residual Solvents (RS) by Gas Chn:~matography (GC) test for <1>><4> content against the , specification limit of NMT1b1141 ppm. The 6><4> batches documented in the<bH'> • '(6Jl4 ) (b) (4) OOSs were rejected and of these batches were and are approved for shipment.tb><4 > batcnes are awaiting to be tb>r•) Your firm reported a full-scale investigation summary report OOS # 310018090 on 4 4 November 30, 2019 to investigate the failure batches of<b>< > content inlbH > I <b><4> The OOS evaluated an out of specification result for1b1141 by Gas Chromatography for batch # ll>HilJ That investigation concluded that a correction 4 with an issue with the (b>< > was rectified and no similar incidents were reported. Additionally, "no impact on the further batches execution." However, batches /1 EAIPl.OYEE(S} NAME ANO nTtE (Pnnl"' r,,,., OATEISSUEO 01/28/2020 7J!Z- Dipesh Shah, CSO Aditi Thakur, Chemist ~.Pt t'ORM fllA 483 (U9/08) PREVIOUS EOmON OOSOt.ETE INSPECTIONAL OBSERVATIONS PAGE I Of 8 MOES DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD ANO DRUG ADMI NISTRATION DISTillCT ~US NIO PHONE N\JMll:R OAff(S)Of 11'1:.Pt.Cfl()N 12420 Parklawn Drive, Room 2032 01/20/2020-01/28/2020 Rockville, MD 20857 fEll<UM6fR 3002949085 ORAPHARMinternational483responses@ f da . hhs . gov NM<EANOT1fl.E()f lllll<ll10l.W. TOWt!OLl~TISSUEO Mr. Arun Gupta, Vice President & Location Head flRl.A'<AME STREET it.DDRESS Dr . Reddy' s Laboratories Limited CTO APIIC Indust rial Estate, Pydibhimavarama Unit VI (Village) CITY, STATE. ZIP uvuE, COUNTRY IY>'t:tS1A8 llSHMENT IHSPECTl!O Srikakulam DisLrict, Andhra Pradesh, API Manufacturer India '(b) (4) _Jwere tested and failed against your specification of NMT (b)(4) of<bH4> content. Batch results were as follows: (b)(4) Notification Date Batch Number I Number Observed Content (ppm) - (b)(4) (b)(4) (b)(4) December 3, 2019 1--1 December 23, r (b)(4~ 2019 '---' Where a list e_rovided during the inspection states that batch numbersCbH•> CtiH•> will beCb>l4> Additionally, during the inspection we found that your finn documented incidents for failed results during process validation. The details are as follows: (b)(4J Notification Initiated Category Batch Number I Number Date Content (b)(4) '(b)(4) - -cb~ ~pm) October Incident 3,2018 ..._ ,_ H August oos 13, 2019 ,___ - August Incident I I ,_ 20,2019 lot::: r (b)(4) August Incident (DJ(4) and I l (b)(4) 20,2019 EJJPl..OVEEJ~JNAME A.NO nTt.E (Pr'"' ot typ.J OATE ISSUEO ~o~ 01/28/2020 Dipash Shah, cso Aditi Thakur, Chemist ~ ~J_M FORM tl>A OJ (09/08) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS PAG E~ OF 8 PAGES DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADM INISTRA TlON DISTRICT DRESS AND PHONE NUMBER 1DATE(SJ OF 1rlSPECTfON 12420 Parklawn Drive, Room 2032 01/20/2020- 01/28/2020 Roc kville, MD 20857 FEINUMBER 3002949085 ORAPHARMint e [email protected] NAf.\EAND nne OF lllOIVIOUAL TOWHOM REPOllT ISSUED Mr. Arun Gupta, Vice President & Location Head ARM NAME STREET ADDRESS Dr . Reddy's Laboratories Li mi ted CTO APIIC Industrial Estate, Pydi bhimavarama Unit VI (Village) Cl"IY STATE. ZIP CODE.. COUNTRY TYPE ESTABLISHMCNT INSPECTED Srikakulam District, Andhra Pradesh, AP! Manufacturer India 4 Your firm continues to have recurrent failures fo tt>>< > residual solvent intended for process validation batches and commercial batches without have a scientifically justified root cause analysis. OBSERVATION 2 Investigations are inadequate in that they do not evaluate all potential root causes. Specifically, A. Investigations for the following Out of Specifications (OOS) and Incidents were not performed adequately. For example, 4 1. For OOS # 310018104 and Incident # 200338632 the initial investigation for"b>< > batch 4 H > with re ort date December 01, 2019 and December 09, 2019 resulted in an in- ---1b)(4l (b)(4) grocess 4 4 (bl\ l fie res amp e passe wttli r)< > fo an the root cause iSdetermined to e y madvertent uman error documented in Incident# 200338632. The batch was then moved for further production, however, during release testing an OOS # 310018104 was observed. The batch failed for Solubility testing on December 09, 2019 and 4 4 4 failed for residual solvent <b>< > content lbll > ppm with release specification 0£<b>< > ppm) on December 23, 2019. During the final release investigation, the most probable cause 4 was identified that the original test results for the in-processr n > was accurate 4 which was initially identified to be'<b>< > % initially identified tobettie samp e. The resampled results were discarded with documented justification. 2. OOS # 310017867 with. report date October 17, 2019 for MW batch # -~ an 4 OOS result was reported forFH > content by LCMS teste at contract laboratory identified lb)(4) (b)(4) . '(b)(4) . as The OOS was for mpunty which was reported as ppm against the 4 specification limit ofl b>< > ppm. Your firm only performed a laboratory investigation. The documented most probaole root cause was determined to be cross contamination of the EMPLQYEE(S) NAME AND nTl.E (Prinl 01 Typo) DATE ISSUED 01/28/2020 Dipesh Shah, CSO Aditi Thakur, Chemist FORM FDA 483 (09/081 PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS PAGE 3 OF 8 PAGES DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS J'.NO PHONE NU'111ER l>ATE(S) OF INSPECTION 12420 Parklawn Drive, Room 2032 01/20/2020- 01/28/2020 Rockville, MD 20857 FEI NUMBER 3002949085 ORAPHARMi nternational483respo nses@fda . hhs .gov NAME ANI) TlTI.E OF INDIVIDUAi. TO WHOM REPORT ISSUED Mr. Arun Gupta, Vice President & Location Head FIRM NAME STREET AOORESS Dr. Reddy' s Laboratories Limited CTO APIIC Industrial Estate, Pydibhimavarama Unit VI (Village) CITY, STATE. ZIP CODE, COUNTRY TYPE E TABUSHMEN"l INSPECTED Srikakulam Dis trict, Andhra Pradesh, API Manufacturer India weighing balance or the micropipette during laboratory analysis without an investigation in the manufacturing area. 3. OOS# 310016984 with report date April 05, 2019 for '<b><4> b[(lll14l . (b)(4) ~b)(4) with an OOS result was reported for Assay analysis. %, c4i::fb><4> %. According to sr.ecification # S-08-IJ-USP/08 states that the specification._s_ar_ e .... 4 4 NLT: <b>< > % and NMT: '<b>< > %. The investigation revealed to be instrumentation failure. A re-analysis was condµcte on April 05, 2019 in which results were found not meeting specifications '<b><4> <b><4> %,'(b><4>-T(b><4> %. Inadequate sci en ti fie justification was provided for the failing reanalysis resuft stating the hypothesis that there is a chance of r~~ from the already used injected vials. '(b)(4l roduct is approved for the mted States market. 4 B. During the inspection we observed that your firm did not initiate investigations for'<b>< > batch # ~b><4> for unknown peaks in residual solvents. According to sectio_n_6_ __1. _2_o_f.. your firm s SOP SOP-GLOB-QC-0018, titled 'Handlin of Extraneous Peaks' criteria for 4 mvestt. at1ons. .cior res1.d uaI so I vents states (b>< > WW (bl(4l consistently". Batcnffl as 4 determmea ~ to h. ave<b>< > -n a--no ·mvest1gat1on--·- .- was cond ucted . The mve. sttgatton. states th at these unknown pea s appear to be isomers o ~b><4> nd no investigation was conducted. 4 C. Risk Assessments titled 'Assessment of'!bll > and (b><4> in~ b><4> A Pis Manufactured at CTO-VI Dr. Reddy's Laboratories Limited' with approved date of March 25, 2019 conducted to assess the potential resence o{<b><4> lbll4> and othertb><4> ; mpurity in <b><4> PJ's. Only a theoretical evaluation of the ey Starting Material (KSM) was evaluated and no KSM was tested b u our firm. Additionallu our firm doesn't test fo ~b><4> 4 lbll > tOr\JiliteaState bound pro ucts. our firm has shipped multiple Datches o .<b><4> A.Pl's to United States and it appears that your costumers were not notified. EMPl.OYEE(S) NAME ANO mu (Prlol « Typo) DATE ISSUED 01/28/2020 Dipesh Shah, CSO Aditi Thakur, Chemist FORM rnA 483 IMIU8) l'REVIO\-S WITIOs 06SOLnE INSPECTIONAL OBSERVATIONS PAGE~ OF 8 PAGES DEPARTMENT Of HEALTH ANO HUMAN SERVICES FOOD AND DRUG ADMINISTRATION OATE(SJOf' INOf'ECTlON 12420 Parklawn Drive, Room 2032 01/20/2020-01/28/2020 Rockville, MD 20857 FEJH\MER 3002949085 [email protected].
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