Ralph M Bernstein

FDA Investigator Report

Designation: BIOLOGIST

Duty Station: Silver Spring MD 20993-0002

Organizations: DHHS FDA CDER OMPT CDER OPQ OBP DBRRIV

Total Inspections: 6

Total 483s Issued: 6

Total Warning Letters Issued: 0

Inspection Details

Longest Inspection: 16 days

Shortest Inspection: 4 days

Average Length of Inspection: 9.0 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2024-02-27Celltrion Inc.YeonsuKorea (the Republic of)3005241015
2022-08-26Biocon Biologics LimitedBengaluruIndia3003981475
2022-08-26Biocon Biologics LimitedElectronics City, BengaluruIndia3015283245
2022-06-03Celltrion Inc.YeonsuKorea (the Republic of)3005241015
2018-09-12KBI Biopharma, Inc.BoulderUnited States3011326133
2016-03-04Lonza Tampa LLCTampaUnited States3001549109

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Download 483s and EIRs for Ralph M Bernstein

Co-Inspectors

NameInspectionsLast Inspection
Zhong Li32024
Arsen Karapetyan22022
Hao Kiet D Phan12024
Hyung-Yul Lee12024
Saleem A Akhtar12024
Junho Pak12022
Wayne E Seifert12022
Michael Shanks12022
Jamie L Dion12018
Scott R Nichols12018
Joanne E King12016

Active Locations

Year-wise Inspection Count