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Gene D. Arcy

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FDA investigator. Took part in 65 inspections of 56 companies, 2016–2026.

Inspections (65)
DateCompanyClassificationProject areaInspection
August 21, 2026Bio-Rad Medical Diagnostics GmbHNot classifiedBlood and Blood Products#1332862
August 13, 2026Sifin Diagnostics GmbHNot classified#1339646
June 25, 2026CSL Behring L.L.C.Not classified#1284730
May 1, 2026PPD Development, L.P.Not classified#1320960
March 20, 2026Viant Holdings, LLCNAIBlood and Blood Products#1313084
February 6, 2026Charles River Laboratories Ireland Ltd.NAIVaccines and Allergenic Products#1307962
February 2, 2026SGS Institut Fresenius GmbHNAIVaccines and Allergenic Products#1306310
January 27, 2026Novartis Pharmaceutical Manufacturing GmbHNAIVaccines and Allergenic Products#1304780
November 7, 2025Baxalta US IncorporatedNot classified#1287588
September 18, 2025Baxalta US Inc.Not classifiedBlood and Blood Products#1279237
June 20, 2025Eurofins Biopharma Product Testing Ireland LimitedNAIHuman Cellular, Tissue, and Gene Therapies#1280309
June 16, 2025Reading Scientific Services LtdNot classifiedVaccine, Allergenic, and Live Biotherapeutic Products#1273930
June 10, 2025Seqirus Vaccines LimitedNAIVaccines and Allergenic Products#1278103
May 7, 2025Maxim Biomedical Inc.Not classified#1270828
March 28, 2025ID Biomedical Corporation of QuebecNot classified#1256961
March 18, 2025Sanofi Pasteur LimitedNot classified#1264024
December 13, 2024Grifols Diagnostic Solutions Inc.Not classified#1258104
November 15, 2024Catalent Maryland IncNot classified#1252977
August 23, 2024NOVA LABORATORIES LIMITEDVAIHuman Cellular, Tissue, and Gene Therapies#1247224
August 13, 2024Protherics UK LimitedVAIBlood and Blood Products#1247072
See all 65 inspections in the dashboard
Documents (57)
  • EIR · FUJIFILM Diosynth Biotechnologies Texas, LLC · August 31, 2021
  • EIR · SAFC Carlsbad Inc. · December 16, 2021
  • EIR · Merck Sharp & Dohme LLC · April 16, 2021
  • EIR · Prolacta Bioscience Inc · March 25, 2014
  • EIR · Emergent Biodefense Operations Lansing LLC · September 27, 2018
  • EIR · California Cryobank, LLC · August 7, 2009
  • 483 · Reading Scientific Services Ltd · June 16, 2025
  • 483 · Valneva Scotland Ltd. · April 24, 2018
  • 483 · Baxalta US Inc. · September 18, 2025
  • 483 · Grifols Therapeutics LLC · October 21, 2016
  • 483 · Kite Pharma, Inc. · August 20, 2019
  • 483 · Valneva Scotland Ltd. · March 5, 2024
  • EIR · SAFC Carlsbad Inc. · September 12, 2019
  • 483 · California Cryobank, Inc · August 7, 2009
  • 483 · Bio-rad Laboratories, Inc. · February 5, 2024
  • 483 · Grifols Biologicals LLC
  • 483 · Kite Pharma, Inc. · October 22, 2021
  • 483 · GlaxoSmithKline Biologicals · September 13, 2022
  • 483 · Bio-Rad · March 7, 2023
  • 483 · Avioq, Inc. · December 5, 2023
  • 483 · Instituto Grifols, S.A.
  • 483 · Grifols Diagnostic Solutions Inc.
  • 483 · Cangene BioPharma, LLC
  • EIR · Seqirus Inc · May 17, 2016
  • 483 · MSD Ireland (Carlow) · June 7, 2022
  • EIR · Kite Pharma, Inc. · August 20, 2019
  • 483 · MedImmune U.K. Limited · March 15, 2024
  • 483 · Seqirus Inc · May 10, 2016
  • 483 · Ortho-Clinical Diagnostics, Inc. · December 9, 2022
  • EIR · Valneva Scotland Ltd. · April 24, 2018
  • 483 · Sanofi Pasteur Limited · March 18, 2025
  • 483 · SAFC Carlsbad Inc. · December 16, 2021
  • 483 · Abbott Laboratories · March 29, 2019
  • 483 · The Abraham J. And Phyllis Katz Cord Blood · January 17, 2020
  • 483 · Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC · September 19, 2023
  • 483 · Pharmacia & Upjohn Company LLC · June 16, 2023
  • 483 · CBR Systems Inc · June 3, 2009
  • 483 · Vericel Corporation · July 21, 2023
  • 483 · Grifols Biologicals LLC · May 3, 2024
  • EIR · Grifols Therapeutics LLC · May 6, 2022
  • 483 · CBR Systems Inc · June 14, 2012
  • 483 · FUJIFILM Diosynth Biotechnologies Texas, LLC · August 31, 2021
  • 483 · Grifols Therapeutics LLC
  • 483 · ALBA Bioscience Limited · March 17, 2023
  • 483 · Biogen U.S. Corporation · October 17, 2023
  • 483 · Grifols Diagnostic Solutions Inc. · February 17, 2022
  • 483 · Merck Sharp & Dohme LLC
  • 483 · Protherics UK Limited · August 13, 2024
  • 483 · PCAS Finland Oy · June 7, 2024
  • 483 · NOVA LABORATORIES LIMITED · August 23, 2024
  • 483 · Grifols Diagnostic Solutions Inc. · December 13, 2024
  • 483 · FinVector Oy · May 28, 2024
  • 483 · Valneva Scotland Ltd. · April 16, 2018
  • EIR · Unknown Company · May 4, 2022
  • 483 · SAFC Carlsbad Inc. · September 12, 2019
  • 483 · CSL Behring L.L.C. · June 25, 2026
  • 483 · Catalent Belgium SA · July 7, 2017
Frequently inspected with (10)
Brentley S. Pittman
4 shared
Lewis K. Antwi
4 shared
Meihong Liu
4 shared
Burnell M. Henry

Investigator

3 shared
Cynthia Jim
3 shared
Mihaly S. Ligmond

CSO

3 shared
Peng Zhou
3 shared
Priscilla M. Pastrana

investigator

3 shared
Scott T. Ballard
3 shared
Anissa M. Cheung
2 shared
Person Information

Name

Gene D. Arcy

ID: a2def947-65fb-4056-84e2-1f89cf944cf0

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