Shirley S Wen

FDA Investigator Report

Designation: CONSUMER SAFETY OFFICER

Duty Station: East Brunswick NJ 08816

Organizations: DHHS FDA ORA OGROP ORA OMPTO OBIMO DBIMOI

Total Inspections: 93

Total 483s Issued: 28

Total Warning Letters Issued: 0

Inspection Details

Longest Inspection: 164 days

Shortest Inspection: 1 days

Average Length of Inspection: 14.2 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2025-01-21Vynacron Dental Resins, Inc.JacksonUnited States2242866
2024-08-22Integra LifeSciences CorporationPlainsboroUnited States1121308
2024-08-22Integra LifeSciences Corp.PrincetonUnited States3003418325
2024-05-15Integra LifeSciences CorporationPlainsboroUnited States1121308
2024-04-18Integra LifeSciences CorporationPlainsboroUnited States1121308
2024-03-04Vineland Syrup Inc.VinelandUnited States2226984
2024-01-08Integrity Medical Devices Inc.HammontonUnited States3002832854
2023-12-01Howmedica Osteonics Corp.MahwahUnited States3003070421
2023-08-18UltraRad CorporationVoorheesUnited States3000149131
2023-07-17Bahadir USA LLCCarneys PointUnited States3005741909

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Download 483s and EIRs for Shirley S Wen

Co-Inspectors

NameInspectionsLast Inspection
Nina Yang112019
Michael Serrano102018
Frank J Marciniak62024
Byungja E Marciante52017
Matthew W Kyle22025
Tyanna N Hadley22022
Bei Yu22019
Dhaval H Patel22016
Jaro P Perera12025
William R Chang12023
Darin S Wiegers12020
Joseph L Despins12020
Mathew T Thomas12019
Michelle A Marsh12018
Anastasia I Offordile12017
Barbara J Maulfair12017
Jean M Mulinde12016
Nicholas A Violand12016
Tressa T Lewis12016
Valerie C Reed12016
Adetutu M Gidado12016

Active Locations

Year-wise Inspection Count

Last Updated: 2025-03-04 07:41:21