Amanda Lewin

FDA Investigator Report

Designation: PHARMACOLOGIST

Duty Station: Silver Spring MD 20993-0002

Organizations: DHHS FDA CDER OMPT CDER OTS OSIS DGDBE

Total Inspections: 28

Total 483s Issued: 7

Total Warning Letters Issued: 0

Inspection Details

Longest Inspection: 10 days

Shortest Inspection: 3 days

Average Length of Inspection: 4.9 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2020-03-06Kyowa Kirin Pharmaceutical Research, Inc.La JollaUnited States3008076127
2020-01-24Lambda Therapeutic Research LTD.AhmedabadIndia3005124764
2020-01-16Zenith Technology Corporation, Ltd.DunedinNew Zealand3006135653
2019-11-22Panexcell Clinical Lab PVT. LTD.Navi MumbaiIndia3009892875
2019-11-15Cohance Lifesciences LimitedHyderabadIndia3009291635
2019-09-27Covance Laboratories, Ltd.HarrogateUnited Kingdom3002806712
2019-08-16Hilltop Research ULCScarboroughCanada3011442307
2019-08-09BioPharma Services Inc.North YorkCanada3006587443
2019-06-12Wockhardt LimitedAurangabadIndia3007523885
2019-06-06Glenmark Pharmaceuticals Ltd.Navi MumbaiIndia3013139848

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Download 483s and EIRs for Amanda Lewin

Co-Inspectors

NameInspectionsLast Inspection
Li-Hong Yeh42018
Kara A Scheibner42018
Melkamu Getie Kebtie32020
Sripal R Mada32017
Makini Cobourne-Duval22020
Gajendiran Mahadevan22019
Hasan A Irier22019
Gopa Biswas22017
Sherri N Rohlf12020
Lori Gioia12019
Courtney N Long12019
Joseph L Despins12019
Thea C Grome12017
Yiyue Zhang12017
Xiaohan Cai12017

Active Locations

Year-wise Inspection Count