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FDA Person
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Michael A. Charles

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FDA investigator. Took part in 75 inspections of 75 companies, 2016–2025.

Inspections (75)
DateCompanyClassificationProject areaInspection
January 31, 2025Baxter CorporationVAIDrug Quality Assurance#1259651
January 22, 2025Element Materials Technology Canada Inc.Not classified#1258899
January 17, 2025Eurofins CDMO Alphora Inc.Not classified#1258608
January 16, 2025Medline Industries, Inc.OAIDrug Quality Assurance#1258730
December 10, 2024Vee Pak, LLCVAIDrug Quality Assurance#1255686
October 25, 2024Shanghai Hengrui Pharmaceutical Co., Ltd.Not classified#1252840
October 18, 2024Shanghai Desano Bio-Pharmaceutical Co., Ltd.Not classified#1252841
October 11, 2024Fujian South Pharmaceutical Co. LtdNAIDrug Quality Assurance#1255220
July 19, 2024Kindos Pharmaceuticals Co., Ltd.VAIDrug Quality Assurance#1244269
July 9, 2024Shandong New Time Pharmaceutical Co. Ltd.VAIDrug Quality Assurance#1244268
May 24, 2024DECCAN REMEDIES LIMITEDNot classified#1239427
May 17, 2024Dr. Reddy's Laboratories Ltd.VAIDrug Quality Assurance#1238809
March 20, 2024ITM Medical Isotopes GmbHOAINew Drug Evaluation#1231113
January 25, 2024BrightGene Pharmaceutical Co., Ltd.(Jiangyun Road)Not classified#1227980
January 16, 2024Lexenpharm (Suzhou) LimitedNot classified#1227981
November 17, 2023Distribuidora Comercial Jafra S.A. de C.V.VAIDrug Quality Assurance#1222907
November 10, 2023Nouryon Chemicals, S.A. de C.V.VAIDrug Quality Assurance#1222472
November 3, 2023Distribuidora de Alimentos Naturales y Nutricionales S.A de C.V.VAIDrug Quality Assurance#1221868
September 21, 2023Shaanxi Hanjiang Pharmaceutical Group Co., Ltd (Gaoxin site)VAIMonitoring of Marketed Animal Drugs, Feed, and Devices#1218824
September 14, 2023Zhejiang Ruibang Laboratories Co., LtdVAIMonitoring of Marketed Animal Drugs, Feed, and Devices#1218823
See all 75 inspections in the dashboard
Documents (53)
  • 483 · TAILSTORM HEALTH INC · July 21, 2021
  • 483 · Denver Solutions, LLC DBA Leiters Health · October 7, 2021
  • 483 · Wiley Chemists Inc. · October 2, 2013
  • 483 · College Pharmacy, Inc. · May 28, 2015
  • 483 · Apitoria Pharma Private Limited · October 28, 2019
  • 483 · Hunter Holmes McGuire Veterans Affairs Medical Center Mammography · March 11, 2015
  • 483 · Polpharma Biologics S.A · March 22, 2022
  • 483 · KBI Biopharma, Inc. · December 3, 2021
  • 483 · Baxter Corporation · January 31, 2025
  • 483 · Gland Pharma Limited, Units I+II Pashamylaram Site · November 7, 2019
  • 483 · Cephas Life Sciences Private Limited · May 18, 2023
  • 483 · Bayer AG · July 27, 2020
  • 483 · Medline Industries, Inc. · January 16, 2025
  • EIR · RUBICON RESEARCH LIMITED · January 27, 2023
  • EIR · Bayer AG · July 27, 2020
  • EIR · Infinity Laboratories LLC · October 29, 2015
  • 483 · Vee Pak, LLC · December 10, 2024
  • EIR · Fujian South Pharmaceutical Co. Ltd · October 11, 2024
  • 483 · ST Pharm Co., Ltd. · November 5, 2018
  • 483 · Polpharma Biologics S.A
  • EIR · Curia New Mexico, LLC · March 20, 2020
  • 483 · Xi'an Livingbond Nonwoven Products Corp., Ltd. · January 7, 2019
  • 483 · Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd. · January 22, 2018
  • 483 · TOLMAR, Inc. · February 24, 2020
  • 483 · Holiday Labs Mexico, S.A. de C.V. · July 23, 2018
  • 483 · L M Manufacturing Limited · February 2, 2022
  • 483 · Rohto-Mentholatum (Vietnam) Co., Ltd. · April 6, 2015
  • 483 · ITM Medical Isotopes GmbH · March 20, 2024
  • 483 · Laboratorios Farmalan, S.A. · March 19, 2019
  • 483 · Zhejiang Apeloa Biotechnology Co., Ltd · September 4, 2023
  • 483 · Zydus Animal Health and Investments Limited · September 23, 2022
  • 483 · Jiangsu Grand Xinyi Pharmaceutical Co., Ltd · September 9, 2019
  • 483 · CIRON DRUGS AND PHARMACEUTICALS PVT LTD · September 21, 2022
  • 483 · Gland Pharma Limited · May 16, 2019
  • 483 · Zhejiang Charioteer Pharmaceutical Co. Ltd. · January 15, 2018
  • 483 · Zhejiang Ruibang Laboratories Co., Ltd · September 11, 2023
  • 483 · Shaanxi Hanjiang Pharmaceutical Group Co., Ltd (Gaoxin site) · September 18, 2023
  • 483 · ATLAS R&D Inc · September 6, 2018
  • 483 · STAQ Pharma, Inc. · September 3, 2020
  • 483 · Dr. Reddy's Laboratories Ltd. · May 17, 2024
  • EIR · KBI Biopharma, Inc. · December 3, 2021
  • 483 · BSO LLC · March 11, 2021
  • EIR · Infinity Laboratories LLC · January 7, 2021
  • 483 · Shandong New Time Pharmaceutical Co. Ltd. · July 1, 2024
  • 483 · Curia New Mexico, LLC · March 20, 2020
  • 483 · F. Hoffmann - La Roche Ltd. · August 5, 2022
  • 483 · Infinity Laboratories LLC · January 7, 2021
  • 483 · Apitoria Pharma Private Limited · October 21, 2019
  • 483 · RUBICON RESEARCH LIMITED · January 27, 2023
  • 483 · Pharmaplast S.A.E. · November 10, 2022
  • 483 · Medline Industries, Inc. · December 8, 2023
  • 483 · Kaysersberg Pharmaceuticals SAS · July 19, 2016
  • 483 · K.C. Pharmaceuticals, Inc · January 22, 2020
Frequently inspected with (8)
Ivis L. Negron Torres
3 shared
Youkeun Kim
3 shared
Angela C. Welker
2 shared
Ana-Maria A. Plapcianu

analyst /Microbiologist

1 shared
Cheryl A. Clausen
1 shared
Richard Ledwidge
1 shared
Tyler M. Peterson
1 shared
Vaishali J. Patel
1 shared
Person Information

Name

Michael A. Charles

Title

Investigator

Role

Regulatory Personnel

ID: f83241f0-ae3b-4535-ac03-e790bbf666ca

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