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FDA Person
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Cynthia Jim

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FDA investigator. Took part in 46 inspections of 46 companies, 2016–2024.

Inspections (46)
DateCompanyClassificationProject areaInspection
November 15, 2024Minsheng Group Shaoxing Pharmaceutical Co., Ltd.Not classified#1264243
November 8, 2024Zhejiang Novus Pharmaceuticals Co. LtdNot classified#1256361
September 5, 2024CSPC Ouyi Pharmaceutical Co., Ltd.Not classified#1239361
August 26, 2024CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. LtdNot classified#1239624
July 5, 2024Anthea Pharma Private LimitedNot classified#1246197
June 25, 2024MSN Laboratories Private LimitedVAIDrug Quality Assurance#1245109
April 26, 2024Biological E. LimitedVAIDrug Quality Assurance#1239879
April 12, 2024Sai Life Sciences LimitedVAIDrug Quality Assurance#1240919
February 21, 2024Haupt Pharma Latina SrlOAIPre-Approval Eval. of Animal Drugs and Food Additives#1237210
February 9, 2024ACS Dobfar SpAVAIMonitoring of Marketed Animal Drugs, Feed, and Devices#1232886
December 21, 2023MSN Laboratories Private Limited (Formulations Division, Unit-II)VAIDrug Quality Assurance#1226168
October 27, 2023Somerset Therapeutics LimitedVAIDrug Quality Assurance#1226714
September 1, 2023Standard Sci-tech Innovation (Qingdao) Pharmaceutical Technology Co., Ltd.Not classified#1222571
August 29, 2023Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)VAIDrug Quality Assurance#1222323
May 30, 2023Qilu Antibiotics Pharmaceutical Co. , Ltd.VAIDrug Quality Assurance#1210065
May 19, 2023Qilu Pharmaceutical (Hainan) Co. Ltd.VAIDrug Quality Assurance#1209088
March 24, 2023IntelGenx Corp.Not classified#1204406
February 20, 2023NerPharMa S.r.l.Not classified#1199864
February 3, 2023Industrias Farmaceuticas Almirall S.A.Not classified#1202867
January 20, 2023Berkshire Sterile Manufacturing, LLCVAIBlood and Blood Products#1202788
See all 46 inspections in the dashboard
Documents (50)
  • 483 · Greer Laboratories, Inc. · November 15, 2013
  • 483 · California Stem Cell Treatment · July 26, 2017
  • 483 · Greer Laboratories, Inc. · August 27, 2015
  • EIR · Valneva Scotland Ltd. · March 6, 2019
  • 483 · Valneva Scotland Ltd. · April 24, 2018
  • 483 · Bioreliance Ltd. · March 23, 2016
  • 483 · Japan Food Research Laboratories, Chitose Laboratory
  • 483 · Stason Pharmaceuticals, Inc. · October 25, 2019
  • EIR · Bioreliance Ltd. · March 15, 2019
  • EIR · Grifols Therapeutics LLC · December 13, 2018
  • 483 · Medinatura New Mexico, inc. · December 18, 2019
  • 483 · Octapharma AB
  • 483 · Panacea Biotec Pharma Limited · June 8, 2022
  • 483 · NAMSA
  • 483 · Industria Farmaceutica Galenica Senese Srl
  • 483 · Immacule Lifesciences Private Limited · June 20, 2022
  • 483 · Japan Food Research Laboratories, Chitose Laboratory · December 20, 2022
  • EIR · NerPharMa S.r.l. · February 20, 2023
  • 483 · Minsheng Group Shaoxing Pharmaceutical Co., Ltd. · November 15, 2024
  • 483 · NerPharMa S.r.l.
  • 483 · Bioreliance Ltd.
  • 483 · Lupin Limited
  • 483 · ADMA Biologics, Inc
  • 483 · Bioreliance Ltd.
  • 483 · Grifols Therapeutics LLC
  • 483 · Biological E. Limited
  • 483 · Emergent BioSolutions Canada Inc. · July 18, 2014
  • 483 · ClinImmune Labs-Univ Colorado Cord Blood Bank and Stem Cell Lab
  • 483 · Adimmune Corporation
  • 483 · Sai Life Sciences Limited
  • 483 · Biogen MA Inc.
  • 483 · Anthea Pharma Private Limited · July 5, 2024
  • EIR · Valneva Scotland Ltd. · April 24, 2018
  • 483 · Alembic Pharmaceuticals Limited
  • EIR · Biogen MA Inc. · February 15, 2019
  • 483 · CSPC Ouyi Pharmaceutical Co., Ltd. · September 5, 2024
  • 483 · ACS Dobfar SpA
  • 483 · Bio Agri Mix LP
  • 483 · Lupin Limited (Biotech Division) · October 14, 2022
  • 483 · Kyowa Kirin Co., Ltd.
  • 483 · Sanofi Vaccines US Inc.
  • 483 · Kyowa Kirin Co., Ltd. · December 14, 2022
  • 483 · Valneva Scotland Ltd. · April 16, 2018
  • 483 · Qilu Antibiotics Pharmaceutical Co. , Ltd. · May 30, 2023
  • 483 · Qilu Pharmaceutical (Hainan) Co. Ltd. · May 11, 2023
  • 483 · Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)
  • 483 · Bio Agri Mix LP · July 29, 2022
  • 483 · Merck Sharp & Dohme LLC · April 17, 2015
  • 483 · Alvotech HF · March 17, 2022
  • 483 · Berkshire Sterile Manufacturing, LLC · January 20, 2023
Frequently inspected with (10)
Gene D. Arcy
3 shared
Susan M. Jackson

investigator

3 shared
Gam S. Zamil

issuing_officer

2 shared
Susan T. Hadman

Microbiologist

2 shared
Suzanne N. Vallez
2 shared
Victoria Spivak

Pharmacist | Consumer Safety Officer

2 shared
Amy A. Johnson
1 shared
Anissa M. Cheung
1 shared
Burnell M. Henry

Investigator

1 shared
Carl A. Perez
1 shared
Person Information

Name

Cynthia Jim

Role

Regulatory Personnel

ID: e0f1c8a7-d787-442a-911c-61e37cd806a6

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