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Leiyun W. Boone

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FDA investigator. Took part in 4 inspections of 4 companies, 2023–2025.

Inspections (4)
DateCompanyClassificationProject areaInspection
July 4, 2025Alvotech HFNot classified#1286888
November 12, 2024FUJIFILM Diosynth Biotechnologies Denmark ApSNot classified#1257821
March 19, 2024Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)Not classified#1242049
March 7, 2023Rentschler Biopharma SENot classified#1202157
Documents (13)
  • 483 · EirGenix, Inc., Zhubei Branch · June 16, 2022
  • 483 · Beigene (Suzhou) Co., Ltd. · June 16, 2023
  • 483 · Rentschler Biopharma Inc. · March 22, 2023
  • 483 · Immunex Rhode Island Corporation · December 7, 2021
  • 483 · Biogen International GmbH
  • 483 · Boehringer Ingelheim BioPharmaceuticals (China) Ltd. · July 9, 2023
  • 483 · Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) · March 19, 2024
  • 483 · ImClone Systems, LLC · July 27, 2023
  • 483 · FUJIFILM Diosynth Biotechnologies Denmark ApS · November 12, 2024
  • 483 · Boehringer Ingelheim Biopharmaceuticals (China) Ltd. · June 9, 2023
  • 483 · Alvotech HF. · July 4, 2025
  • 483 · Alvotech HF · July 4, 2025
  • 483 · Rentschler Biopharma SE · March 7, 2023
Frequently inspected with (10)
Caryn M. Mcnab
1 shared
David D. Anderson
1 shared
Della Shin

Pharmaceutical Scientist

1 shared
Ekaterina Allen

Pharmaceutical Scientist

1 shared
Hyung-yul Lee
1 shared
Kathryn E. King
1 shared
Olumide A. Martins
1 shared
Richard Ledwidge
1 shared
Wendy G. Tan
1 shared
Zhong Li
1 shared
Person Information

Name

Leiyun W. Boone

Title

Lead Biologist

Role

ISSUING OFFICER

ID: 454ce531-ae82-4ae4-9b3d-8e4e8afed127

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