Yun Wu

FDA Investigator Report

Total Inspections: 10

Total 483s Issued: 9

Total Warning Letters Issued: 0

Inspection Details

Longest Inspection: 14 days

Shortest Inspection: 5 days

Average Length of Inspection: 9.2 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2023-10-17Patheon Biologics Australia Pty LtdWoolloongabbaAustralia3010976475
2023-08-07Akeso Biopharma, Co., Ltd.ZhongshanChina3017057933
2023-03-28MSD International GmbHSwordsIreland3017657338
2022-06-16EirGenix IncZhubei CityTaiwan3018317024
2022-05-04Tanvex BioPharma USA, IncSan DiegoUnited States3013021112
2022-03-15Eli Lilly Kinsale Ltd.KinsaleIreland3002806888
2021-08-24Samsung Biologics Co., Ltd.YeonsuKorea (the Republic of)3010479596
2021-04-21FujiFilm Diosynth Biotechnologies U.S.A., Inc.Research Triangle ParkUnited States3000718852
2020-08-14Patheon Manufacturing Services LLCGreenvilleUnited States1018495
2020-02-15Novartis Singapore Pharmaceutical Manufacturing Pte.SingaporeSingapore3012958979

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Co-Inspectors

NameInspectionsLast Inspection
Zhong Li12023
Cassandra L Abellard12023
Michael Shanks12023
Maria G Gutierrez-Hoffman12022
Arulvathani P Arudchandran12022
Junho Pak12022
Christopher R Czajka12022
Jacek Cieslak12021
Zhihao Pete Qiu12021
Seneca D Toms12021
Viviana Matta12020
Thuy T Nguyen12020

Active Locations

Year-wise Inspection Count