Zhong Li

FDA Investigator Report

Designation: CHEMIST

Duty Station: Silver Spring MD 20993-0002

Organizations: DHHS FDA CDER OMPT CDER OPQ OPF DIA IABI

Total Inspections: 41

Total 483s Issued: 38

Total Warning Letters Issued: 0

Inspection Details

Longest Inspection: 16 days

Shortest Inspection: 3 days

Average Length of Inspection: 7.9 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2024-05-24Patheon Manufacturing Services LLCGreenvilleUnited States1018495
2024-02-27Celltrion Inc.YeonsuKorea (the Republic of)3005241015
2023-08-07Akeso Biopharma, Co., Ltd.ZhongshanChina3017057933
2023-06-16Beigene (Suzhou) Co., Ltd.SuzhouChina3014150588
2023-06-09Boehringer Ingelheim Biopharmaceuticals (China) Ltd.ShanghaiChina3015009021
2023-03-10Hugel Inc.ChuncheonKorea (the Republic of)3012163998
2023-02-24Janssen Vaccines Corp.Beon-Gil, YeonsuKorea (the Republic of)3012637764
2023-02-10AGC Biologics, Inc.BothellUnited States3000209996
2023-01-24Alexion Pharma International Operations Unlimited Co.Dublin 15Ireland3012889718
2022-11-18Patheon Italia S.p.A.MonzaItaly3003065803

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Download 483s and EIRs for Zhong Li

Co-Inspectors

NameInspectionsLast Inspection
Jacek Cieslak42023
Ralph M Bernstein32024
Arsen Karapetyan32022
Michael Shanks32022
Kham Phommachanh32019
Esther C Broner22022
Richard Ledwidge22022
Zhihao Pete Qiu22017
Maria J Lopez- Barragan22017
Hao Kiet D Phan12024
Hyung-Yul Lee12024
Melanie M Walker12024
Saundrea A Munroe12024
Saleem A Akhtar12024
Charles Y Kuo12023
Yiwei Li12023
Yetao Jin12023
Yuan-Chia Kuo12023
Yun Wu12023
Michael Araneta12023
Andrew K Haack12023
Tonia F Bernard12023
Melissa D Ray12022
Alan P Kurtzberg12022
Jose E Melendez12022
Virginia A Carroll12019
William Hallett12019
Reyes Candau-Chacon12018
Zhao Wang12018
Marcus A Ray12018
Marion Michaelis12017
Scott R Nichols12017
Diane L Raccasi12017
Zhigang Sun12016
Margaret M Annes12016

Active Locations

Year-wise Inspection Count