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Madushini N. Dharmasena

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FDA investigator. Took part in 18 inspections of 17 companies, 2019–2026.

Inspections (18)
DateCompanyClassificationProject areaInspection
May 5, 2026Thermo Fisher Biopharma Services PTE. LTDNot classified#1320412
March 27, 2026Q-Med ABNot classified#1313816
November 7, 2025Allergan Sales, LLCNot classified#1285134
September 12, 2025Dr. Reddy's Laboratories, Ltd, BiologicsNot classified#1285128
May 15, 2025GlaxoSmithKline Manufacturing S.p.A.Not classified#1285374
March 28, 2025Chiesi Farmaceutici S.p.A.Not classified#1268341
January 16, 2025Sanofi-Aventis Deutschland GmbHNot classified#1262770
November 14, 2024SEIKAGAKU CORPORATION KURIHAMA PLANTNot classified#1263493
June 4, 2024Wuxi Biologics Co LtdNot classified#1274331
March 8, 2024CSL Behring (Australia) Pty LtdNot classified#1235576
December 14, 2023Horizon Therapeutics Ireland Designated Activity Company (DAC)Not classified#1238069
October 12, 2023Dr. Reddy's Laboratories, Ltd, BiologicsNot classified#1223516
September 21, 2023PharmaEssentia Corporation, Taichung PlantNot classified#1224775
May 11, 2023Pfizer Ireland Pharmaceuticals Unlimited CompanyNot classified#1208210
April 21, 2023UCB Pharma S.A.Not classified#1208307
March 16, 2023Bio-Technology General (Israel), Ltd.Not classified#1202488
June 18, 2019Lonza Biologics Tuas Pte LtdNot classified#1108095
March 15, 2019GlaxoSmithKline dba Human Genome Sciences IncNot classified#1108003
Documents (26)
  • 483 · Immunomedics, Inc. · August 6, 2018
  • EIR · UCB Pharma S.A. · April 21, 2023
  • 483 · Dr. Reddy’s Laboratories, LTD, Biologics · September 12, 2025
  • 483 · Immunomedics, Inc.
  • 483 · Janssen Sciences Ireland UC · April 30, 2021
  • 483 · Chiesi Farmaceutici S.p.A. · March 28, 2025
  • 483 · Regeneron Ireland Designated Activity Company · May 7, 2021
  • 483 · Pfizer Ireland Pharmaceuticals Unlimited Company · May 11, 2023
  • 483 · GlaxoSmithKline Manufacturing S.p.A. · May 15, 2025
  • 483 · Dr. Reddy's Laboratories, LTD, Biologics · September 12, 2025
  • 483 · Kyowa Kirin Co., Ltd.
  • 483 · Dr. Reddy's Laboratories, Ltd, Biologics · September 12, 2025
  • 483 · CSL Behring (Australia) Pty Ltd · March 8, 2024
  • 483 · Allergan Sales, LLC · November 7, 2025
  • 483 · Samsung Biologics Co., Ltd. · June 9, 2022
  • 483 · Dr. Reddy's Laboratories, Ltd, Biologics · October 12, 2023
  • 483 · GlaxoSmithKline dba Human Genome Sciences Inc · March 15, 2019
  • 483 · Sanofi-Aventis Deutschland GmbH · January 16, 2025
  • 483 · Hugel Inc. · August 20, 2021
  • 483 · Q-Med AB · March 27, 2026
  • 483 · Thermo Fisher Biopharma Services PTE. LTD · May 5, 2026
  • 483 · PharmaEssentia Corporation, Taichung Plant · September 21, 2023
  • 483 · Alvotech HF · March 17, 2022
  • 483 · Bio-Technology General (Israel), Ltd. · March 16, 2023
  • 483 · UCB Pharma SA, Braine · April 21, 2023
  • 483 · UCB Pharma S.A. · April 21, 2023
Frequently inspected with (10)
Maria G. Gutierrez-Hoffman
2 shared
Olumide A. Martins
2 shared
Thuy T. Nguyen

Investigator, Consumer Safety Officer

2 shared
Ying Zhang
2 shared
Alice S. Tsao

Consumer Safety Officer at FDA

1 shared
Baikuntha Aryal

Pharmaceutical Scientist

1 shared
Cassandra L. Abellard

investigator

1 shared
Jiangsong Jiang
1 shared
Joao A. Pedras Vasconcel
1 shared
Jun Liu
1 shared
Person Information

Name

Madushini N. Dharmasena

ID: c6dbff15-4c5f-475e-8ec1-581d8e65f76c

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