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Zhong Li

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FDA investigator. Took part in 36 inspections of 35 companies, 2017–2026.

Inspections (36)
DateCompanyClassificationProject areaInspection
March 20, 2026Bora Pharmaceuticals Injectables IncNot classifiedDrug Quality Assurance#1308344
January 9, 2026QOL Medical LLCNot classified#1298622
December 15, 2025Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (FDF Site)Not classified#1295788
July 4, 2025Alvotech HFNot classified#1286888
May 16, 2025Goodwin Biotechnology, Inc.Not classified#1270377
March 11, 2025FUJIFILM Diosynth Biotechnologies Texas, LLCNot classified#1268686
January 24, 2025Shanghai Henlius Biologics Co., Ltd.Not classified#1287688
December 13, 2024KOFU FACTORY OF TERUMO CORP.Not classified#1287452
October 15, 2024Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory)Not classified#1288932
September 25, 2024GlaxoSmithKline, LLC.Not classified#1261906
August 30, 2024Patheon Manufacturing Services LLCNot classified#1271322
July 30, 2024Samsung Biologics Co., Ltd.Not classified#1261652
May 24, 2024Patheon Manufacturing Services LLCNot classifiedDrug Quality Assurance#1238532
February 27, 2024Celltrion Inc.VAIDrug Quality Assurance#1233221
February 6, 2024Amgen, Inc.Not classified#1240449
August 7, 2023Akeso Biopharma Co., Ltd.Not classified#1218071
June 16, 2023Beigene (Suzhou) Co., Ltd.VAIDrug Quality Assurance#1217639
June 9, 2023Boehringer Ingelheim Biopharmaceuticals (China) Ltd.Not classified#1218076
April 11, 2023Chiesi Farmaceutici S.p.A.Not classified#1215852
March 10, 2023Hugel Inc.Not classified#1205451
See all 36 inspections in the dashboard
Documents (45)
  • 483 · Biocon Biologics Limited · August 26, 2022
  • EIR · Samsung Biologics Co., Ltd. · July 30, 2024
  • 483 · Chugai Pharma Manufacturing Co., Ltd., Ukima Plant · August 23, 2021
  • 483 · FUJIFILM Diosynth Biotechnologies Texas, LLC · March 11, 2025
  • 483 · Amgen, Inc. · February 6, 2024
  • 483 · KOFU FACTORY OF TERUMO CORP. · December 13, 2024
  • 483 · Pharmadax (Foshan) Co., Ltd (Heshun Plant) · March 11, 2019
  • 483 · Merck Serono SA · July 8, 2022
  • 483 · Goodwin Biotechnology, Inc. · May 16, 2025
  • 483 · BioMarin International Limited · May 2, 2017
  • 483 · Amgen Manufacturing Ltd · February 27, 2020
  • 483 · Biocon Biologics Limited · August 26, 2022
  • EIR · Hugel Inc. · March 10, 2023
  • 483 · Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (FDF Site) · December 15, 2025
  • 483 · BioMarin International Limited
  • 483 · Granules Pharmaceuticals Inc. · October 26, 2018
  • 483 · Intas Pharmaceuticals Ltd. · August 9, 2022
  • 483 · Patheon Manufacturing Services LLC · May 24, 2024
  • 483 · Baxter Oncology GmbH · November 5, 2019
  • 483 · Hugel Inc. · March 10, 2023
  • 483 · Samsung Biologics Co., Ltd. · July 25, 2017
  • 483 · Shanghai Henlius Biologics Co., Ltd. · January 24, 2025
  • 483 · Celltrion Inc. · February 27, 2024
  • 483 · Akeso Biopharma Co., Ltd. · August 7, 2023
  • 483 · Boehringer Ingelheim BioPharmaceuticals (China) Ltd. · July 9, 2023
  • 483 · QOL Medical LLC · January 9, 2026
  • 483 · Bora Pharmaceuticals Injectables Inc · March 20, 2026
  • 483 · Patheon Manufacturing Services LLC · August 30, 2024
  • 483 · Curia New Mexico, LLC · April 11, 2022
  • 483 · AGC Biologics, Inc. · February 10, 2023
  • 483 · MacroGenics, Inc · April 6, 2021
  • EIR · Patheon Manufacturing Services LLC · May 24, 2024
  • 483 · Shanghai Henlius Biologics Co., Ltd. · January 24, 2025
  • 483 · Alvotech HF. · July 4, 2025
  • 483 · Sharp Packaging Services, LLC · September 21, 2022
  • 483 · Patheon Italia S.p.A. · November 18, 2022
  • 483 · Kyowa Kirin Co., Ltd. · August 30, 2021
  • 483 · Chugai Pharma Manufacturing Co. Ltd. (CPMC) · August 23, 2021
  • 483 · Alexion Pharma International Operations Unlimited Co. · January 24, 2023
  • 483 · Boehringer Ingelheim Biopharmaceuticals (China) Ltd. · June 9, 2023
  • 483 · GlaxoSmithKline, LLC. · September 25, 2024
  • 483 · Samsung Biologics Co., Ltd. · July 30, 2024
  • 483 · Sigma-Aldrich Manufacturing LLC · January 31, 2020
  • 483 · FUJIFILM Diosynth Biotechnologies Denmark ApS
  • 483 · Alvotech HF · July 4, 2025
Frequently inspected with (10)
Hyung-yul Lee
3 shared
Charles Y. Kuo

issuing_officer

2 shared
Della Shin

Pharmaceutical Scientist

2 shared
Ekaterina Allen

Pharmaceutical Scientist

2 shared
Jie He
2 shared
Marcus A. Ray

Supervisory Consumer Safety Officer, China Office

2 shared
Maria J. Lopez- Barragan
2 shared
Ralph M. Bernstein
2 shared
Saundrea A. Munroe

Drug Specialist / Drug Investigator

2 shared
Yi Wang

Regulatory Scientist at FDA

2 shared
Person Information

Name

Zhong Li

ID: 18545b20-7fa5-4850-9dd4-cffb40c41f8d

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