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Richard Ledwidge

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FDA investigator. Took part in 21 inspections of 21 companies, 2017–2024.

Inspections (21)
DateCompanyClassificationProject areaInspection
November 12, 2024FUJIFILM Diosynth Biotechnologies Denmark ApSNot classified#1257821
September 20, 2024Vetter Pharma Fertigung GmbH & Co. KGNot classified#1248795
July 26, 2024Biocon Biologics LimitedVAIDrug Quality Assurance#1245708
April 30, 2024CSL Behring GmbHNot classified#1242677
March 20, 2024Roche Diagnostics GmbHNot classified#1242676
February 1, 2024Hugel Inc.Not classified#1250653
December 14, 2023Suzhou Suncadia Biopharmaceuticals Co., Ltd.Not classified#1242894
September 12, 2023Fournier Laboratories Ireland, Ltd. (Abbvie Cork)Not classified#1223466
September 5, 2023Patheon Italia S.p.A.Not classified#1223465
August 1, 2023Gan & Lee PharmaceuticalsNot classified#1222758
May 22, 2023Sanofi S.r.l.Not classified#1219964
May 10, 2023Merck Serono S.p.A.Not classified#1222768
March 17, 2023Alvotech HFNot classified#1208850
March 2, 2023Protalix Ltd.Not classified#1234244
January 24, 2023Patheon Biologics LLCNot classified#1206368
July 11, 2019Bio-Technology General (Israel), Ltd.VAIDrug Quality Assurance#1097973
November 23, 2018Boehringer Ingelheim RCV GmbH & Co KGNot classified#1078568
September 12, 2018Eli Lilly Kinsale Ltd.Not classified#1071707
July 17, 2018Celltrion Inc.VAIDrug Quality Assurance#1061388
April 27, 2018Sanofi Winthrop IndustrieNot classified#1053482
See all 21 inspections in the dashboard
Documents (27)
  • EIR · Hanmi Pharma Co., Ltd · June 2, 2021
  • 483 · Biocon Sdn. Bhd. (Company No. 201101002193) · August 30, 2022
  • 483 · Celltrion Inc. · July 17, 2018
  • 483 · Eli Lilly Kinsale Ltd. · March 16, 2018
  • 483 · Alexion Pharma International Operations Unlimited Co. · April 8, 2022
  • 483 · Alvotech HF · March 17, 2023
  • 483 · Hugel Inc. · February 1, 2024
  • 483 · Merck Serono SA · July 8, 2022
  • 483 · Vetter Pharma Fertigung GmbH & Co. KG · September 20, 2024
  • 483 · Biocon Sdn. Bhd. (Company No. 201101002193)
  • 483 · Boehringer Ingelheim Fremont, Inc. · April 4, 2017
  • 483 · Patheon Italia S.p.A. · September 5, 2023
  • 483 · Alexion Pharma International Operations Unlimited Co.
  • 483 · Eli Lilly Kinsale Ltd.
  • 483 · FUJIFILM Diosynth Biotechnologies Denmark ApS · November 12, 2024
  • 483 · Fournier Laboratories Ireland, Ltd. (Abbvie Cork) · September 12, 2023
  • 483 · Immunex Rhode Island Corporation · December 7, 2021
  • 483 · CSL Behring GmbH · April 30, 2024
  • 483 · Sanofi S.r.l. · May 22, 2023
  • 483 · Challenge Bioproducts Company, Ltd. · October 31, 2022
  • 483 · Suzhou Suncadia Biopharmaceuticals Co., Ltd. · December 14, 2023
  • 483 · Biogen International GmbH
  • 483 · Biocon Biologics Limited
  • 483 · Boehringer Ingelheim RCV GmbH & Co KG · November 19, 2018
  • 483 · Merck Serono S.p.A. · May 10, 2023
  • 483 · Patheon Biologics LLC · January 24, 2023
  • 483 · Biocon Biologics Limited · July 26, 2024
Frequently inspected with (10)
Thuy T. Nguyen

Investigator, Consumer Safety Officer

2 shared
Abdollah Koolivand
1 shared
Anh Lac
1 shared
Arsen Karapetyan
1 shared
Ashar P. Parikh
1 shared
Cassandra L. Abellard

investigator

1 shared
Charles Y. Kuo

issuing_officer

1 shared
Christopher D. Downey
1 shared
David D. Anderson
1 shared
Derek S. Smith
1 shared
Person Information

Name

Richard Ledwidge

ID: aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9

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