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Marcellinus D. Dordunoo

View detailed information about Marcellinus D. Dordunoo, including compliance records, violations, and related data.

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FDA investigator. Took part in 72 inspections of 69 companies, 2016–2026.

Inspections (72)
DateCompanyClassificationProject areaInspection
August 27, 2026Chengdu Shengnuo Biopharm Co LtdNot classified#1334998
July 3, 2026Wuxi Biologics Co LtdNot classified#1324932
May 8, 2026Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)Not classified#1322276
April 24, 2026Zhejiang Huahai Pharmaceutical Co., Ltd.Not classified#1319736
July 31, 2025GlaxoSmithKline dba Human Genome Sciences IncNot classified#1277363
May 16, 2025INTERVEIN RESEARCH LABS PRIVATE LIMITEDVAIDrug Quality Assurance#1269556
May 12, 2025Amneal Pharmaceuticals PrivateOAIGeneric Drug Evaluation#1269875
February 20, 2025Syngene International Ltd.Not classified#1267516
February 7, 2025Hikal LimitedOAIMonitoring of Marketed Animal Drugs, Feed, and Devices#1260407
November 22, 2024Rakshit Drugs Private LimitedNot classified#1258905
November 15, 2024Sionc Pharmaceuticals Private LimitedNot classified#1258402
November 8, 2024Chromcore Lifesciences LLPVAIGeneric Drug Evaluation#1254313
September 30, 2024Airgas USA, LLCVAIDrug Quality Assurance#1250811
June 28, 2024Yangtze River Pharmaceutical (Group) Co., Ltd.VAIGeneric Drug Evaluation#1245074
June 18, 2024Zhaoke Pharmaceutical (Hefei) Company LimitedOAINew Drug Evaluation#1245073
May 2, 2024Wasserburger Arzneimittelwerk GmbHNAIDrug Quality Assurance#1240649
April 23, 2024GE Healthcare ASVAIDrug Quality Assurance#1236691
February 29, 2024Eugia SEZ Private LimitedNot classifiedDrug Quality Assurance#1231363
February 16, 2024First Source Laboratory Solutions LLPVAIGeneric Drug Evaluation#1230226
December 19, 2023Xiamen Tiger Medical Co., Ltd.VAIDrug Quality Assurance#1227225
See all 72 inspections in the dashboard
Documents (53)
  • 483 · HV Pharmacy dba Hunt Valley Pharmacy · August 17, 2018
  • 483 · Apex Pharmacy, LLC · November 7, 2019
  • 483 · Eugia SEZ Private Limited · February 29, 2024
  • WARNING LETTER RESPONSE · Unknown Company · September 23, 2004
  • STATE REFERRAL LETTER · Unknown Company · June 12, 2015
  • 483 · Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical · March 23, 2017
  • EIR · Quality Packaging Specialists International, LLC · November 3, 2017
  • 483 · Fresenius Kabi USA, LLC · August 12, 2019
  • 483 · Aromas Para El Alma S.A. · October 19, 2023
  • 483 · Pharmaceutics International Inc · September 29, 2021
  • 483 · Sionc Pharmaceuticals Private Limited · November 15, 2024
  • 483 · Syngene International Ltd. · February 20, 2025
  • 483 · GFA Production Xiamen Co., Ltd. · December 8, 2023
  • EIR · Pharmaceutics International, Inc. · September 29, 2021
  • 483 · UBI Pharma, Inc. · June 6, 2023
  • 483 · Lupin Limited · January 10, 2020
  • 483 · Sumitomo Chemical Co., Ltd. · December 8, 2017
  • 483 · Hikal Limited · February 7, 2025
  • 483 · Bell-More Labs, Inc. · June 7, 2021
  • 483 · Chromcore Lifesciences LLP · November 8, 2024
  • 483 · Rakshit Drugs Private Limited · November 22, 2024
  • 483 · GlaxoSmithKline dba Human Genome Sciences Inc · July 31, 2025
  • 483 · Zencore Biologics Co., Ltd. · September 6, 2023
  • EIR · Fresenius Kabi USA, LLC · August 12, 2019
  • 483 · Xiamen Tiger Medical Co., Ltd. · December 19, 2023
  • EIR · Emergent Manufacturing Operations Baltimore LLC. · April 20, 2020
  • EIR · Lab Ofichem B.V. · September 18, 2019
  • 483 · SriSai Biopharmaceutical Solutions LLC · February 23, 2023
  • 483 · Lilly France S.A.S. · September 29, 2022
  • 483 · Roberts Oxygen Company Inc · December 12, 2019
  • 483 · Tayca Corporation · December 15, 2017
  • 483 · Safe Chain Solutions, Llc · May 10, 2022
  • 483 · Alembic Pharmaceuticals Limited · December 16, 2022
  • 483 · Nutra-Med Packaging Inc. · June 29, 2016
  • 483 · Biocon Limited · January 24, 2020
  • 483 · TERUMO YAMAGUCHI CORPORATION · March 30, 2023
  • 483 · NATCO Pharma Limited · June 5, 2019
  • 483 · Zhaoke Pharmaceutical (Hefei) Company Limited · June 18, 2024
  • 483 · KOFU FACTORY OF TERUMO CORP. · March 21, 2023
  • 483 · SUCO, Inc. · August 2, 2017
  • 483 · Duchesnay Inc. · October 27, 2023
  • 483 · Qilu Pharmaceutical Co., Ltd. · February 22, 2018
  • 483 · Emergent Manufacturing Operations Baltimore LLC. · April 20, 2020
  • 483 · ChiRhoClin, Inc · November 3, 2022
  • 483 · Glenmark Pharmaceuticals Limited · June 22, 2022
  • EIR · ABRYL LABORATORIES PRIVATE LIMITED · December 6, 2022
  • 483 · Amneal Pharmaceuticals Private · May 12, 2025
  • 483 · Zhejiang Huahai Pharmaceutical Co., Ltd. · April 24, 2026
  • 483 · Pharmaceutics International, Inc. · September 29, 2021
  • 483 · Centrient Pharmaceuticals India Private Limited · July 1, 2022
  • 483 · Henan Kangdi Medical Devices Co. Ltd · March 7, 2019
  • 483 · ABRYL LABORATORIES PRIVATE LIMITED · December 6, 2022
  • 483 · Chengdu Shengnuo Biopharm Co Ltd · August 27, 2026
Frequently inspected with (10)
Hung H. Do
3 shared
Jessica P. Mcalister

Pharmacy Compounding National Expert at FDA

3 shared
Eileen A. Liu
2 shared
Melanie W. Pishnery
2 shared
Nicole E. Knowlton

Investigator

2 shared
Patric C. Klotzbuecher
2 shared
Taichun Qin

Consumer Safety Officer, Drug Specialist

2 shared
Ashar P. Parikh
1 shared
Carrie A. Hughes
1 shared
Catherine O. Lamptey

issuing_officer

1 shared
Person Information

Name

Marcellinus D. Dordunoo

Title

Investigator

Role

Regulatory Personnel

ID: a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a

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