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Wayne E. Seifert

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FDA investigator. Took part in 44 inspections of 40 companies, 2016–2026.

Inspections (44)
DateCompanyClassificationProject areaInspection
September 1, 2026FUJIFILM Diosynth Biotechnologies UK LimitedNot classified#1339338
June 10, 2026Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma ServicesNot classifiedDrug Quality Assurance#1321518
May 1, 2026ImmunityBio, Inc.Not classified#1321650
March 10, 2026Hospira, Inc., A Pfizer CompanyNot classified#1310592
November 11, 2025Loba Feinchemie GmbHNot classified#1299824
September 16, 2025Amgen Technology (Ireland) Unlimited CompanyNot classified#1278033
June 24, 2025Cilag AGNot classified#1279364
April 15, 2025MABXIENCE S.A.U.Not classified#1272276
March 21, 2025Teva Biotech GmbHNot classified#1270325
February 18, 2025Patheon Italia S.p.ANot classified#1269289
January 17, 2025Genzyme Ireland LimitedNot classified#1260340
November 12, 2024Takeda Austria GmbHNot classified#1256112
September 24, 2024Baxter Pharmaceutical Solutions, LLCNot classified#1242468
August 27, 2024Baxter Oncology GmbHNot classified#1249702
June 7, 2024AstraZeneca Pharmaceuticals LPNot classified#1242118
May 17, 2024Pfizer Manufacturing Belgium NVNot classified#1239799
November 7, 2023FUJIFILM Diosynth Biotechnologies Texas, LLCNot classified#1226149
October 6, 2023Eli Lilly & CompanyNot classified#1220489
September 1, 2023Samsung Biologics Co., Ltd.VAIDrug Quality Assurance#1218067
July 27, 2023ImClone Systems, LLCNot classified#1217252
See all 44 inspections in the dashboard
Documents (62)
  • EIR · AGC Biologics, Inc. · March 19, 2021
  • 483 · Patheon Italia S.p.A · February 18, 2025
  • 483 · Biocon Sdn. Bhd. (Company No. 201101002193) · September 24, 2021
  • EIR · Rentschler Biopharma SE · February 15, 2022
  • EIR · UCB Pharma S.A. · February 4, 2022
  • 483 · Sandoz GmbH · December 17, 2021
  • 483 · MABXIENCE S.A.U. · April 7, 2025
  • 483 · Catalent Belgium SA · October 26, 2021
  • EIR · Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC · May 3, 2019
  • 483 · AGC Biologics, Inc. · March 19, 2021
  • 483 · ImClone Systems, LLC · July 27, 2023
  • 483 · Cilag AG · June 16, 2025
  • 483 · FUJIFILM Diosynth Biotechnologies Texas, LLC · November 7, 2023
  • 483 · Genzyme Corporation · September 4, 2020
  • EIR · Genzyme Corporation · September 4, 2020
  • EIR · Baxter Oncology GmbH · August 27, 2024
  • 483 · Samsung Biologics Co., Ltd. · September 10, 2019
  • 483 · Amgen Technology (Ireland) Unlimited Company · September 8, 2025
  • 483 · ALCON-COUVREUR N.V. · November 5, 2021
  • 483 · Wyeth Pharmaceutical Division of Wyeth Holdings LLC · March 17, 2017
  • 483 · Allergan Pharmaceuticals Ireland · December 17, 2019
  • 483 · Shire Human Genetic Therapies, Inc. · March 23, 2022
  • 483 · Eli Lilly Italia SPA · February 10, 2023
  • 483 · Vetter Pharma Fertigung GmbH & Co. KG · August 19, 2022
  • 483 · Celltrion Inc. · June 3, 2022
  • 483 · Loba Feinchemie GmbH · November 3, 2025
  • 483 · FUJIFILM Diosynth Biotechnologies Denmark ApS
  • 483 · Patheon Biologics B.V. · September 20, 2018
  • 483 · Biofortuna Limited · February 1, 2019
  • 483 · Patheon Italia S.p.A
  • 483 · Pfizer Manufacturing Belgium NV · May 17, 2024
  • 483 · TERUMO YAMAGUCHI CORPORATION · February 21, 2020
  • 483 · Lonza Biologics, Inc. · November 3, 2020
  • 483 · Genzyme Ireland Limited · January 9, 2025
  • 483 · Eli Lilly & Company · June 16, 2023
  • 483 · Biogen MA Inc. · June 16, 2021
  • 483 · Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC · May 3, 2019
  • 483 · UCB Pharma S.A. · February 4, 2022
  • 483 · Novartis Pharma Stein AG · December 6, 2022
  • EIR · Biogen MA Inc. · June 16, 2021
  • 483 · Baxter Oncology GmbH · August 27, 2024
  • 483 · Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) · August 26, 2022
  • 483 · Packaging Coordinators, LLC · January 12, 2023
  • 483 · Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services · April 15, 2021
  • 483 · Rentschler Biopharma SE · February 15, 2022
  • 483 · Catalent Indiana, LLC · May 12, 2023
  • 483 · Fresenius Kabi Austria GMBH · March 28, 2023
  • 483 · Eli Lilly & Company · October 6, 2023
  • 483 · F. Hoffmann-La Roche AG
  • 483 · Woodstock Sterile Solutions Inc · June 25, 2019
  • 483 · Norbitec GmbH · April 6, 2023
  • 483 · AstraZeneca Pharmaceuticals LP · June 7, 2024
  • 483 · Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services · November 5, 2020
  • 483 · Lupin Limited (Biotech Division) · October 14, 2022
  • 483 · Novartis Pharma Stein AG · September 21, 2018
  • 483 · Thermo Fisher Scientific (Patheon Italia S.p.A.) · February 18, 2025
  • 483 · Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services · June 10, 2026
  • 483 · Immunomedics, Inc. · March 10, 2020
  • 483 · Teva Biotech GmbH · March 13, 2025
  • EIR · Lonza Biologics, Inc. · November 3, 2020
  • 483 · Hospira, Inc., A Pfizer Company · March 10, 2026
  • 483 · FUJIFILM Diosynth Biotechnologies UK Limited · September 1, 2026
Frequently inspected with (10)
Maria J. Lopez- Barragan
3 shared
Diane L. Raccasi
2 shared
Andrea Franco

Pharmaceutical Scientist

1 shared
Armen H. Youssoufian
1 shared
Arulvathani P. Arudchandran
1 shared
Bo Chi
1 shared
Brandy N. Lepage

Consumer Safety Officer

1 shared
Cassandra L. Abellard

investigator

1 shared
Christina K. Theodorou

Consumer Safety Officer

1 shared
Daniel L. Zheng

M.S., Consumer Safety Officer at FDA

1 shared
Person Information

Name

Wayne E. Seifert

Title

Senior Regulatory Specialist

ID: e92e1f10-c61e-4b08-9156-25907e5e2942

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