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Charles Y. Kuo

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FDA investigator. Took part in 8 inspections of 8 companies, 2023–2026.

Inspections (8)
DateCompanyClassificationProject areaInspection
April 27, 2026Agricultural Technology Research Institute (ATRI)Not classified#1315316
March 4, 2025Akeso Biopharma Co., Ltd.Not classified#1275502
July 30, 2024Samsung Biologics Co., Ltd.Not classified#1261652
April 30, 2024CSL Behring GmbHNot classified#1242677
November 15, 2023Catalent Indiana, LLCVAIVaccines and Allergenic Products#1224264
March 24, 2023Rentschler Biopharma Inc.Not classified#1202865
February 10, 2023FujiFilm Diosynth Biotechnologies U.S.A., Inc.Not classified#1218019
February 10, 2023AGC Biologics, Inc.VAIDrug Quality Assurance#1197098
Documents (7)
  • EIR · Samsung Biologics Co., Ltd. · July 30, 2024
  • 483 · Akeso Biopharma Co., Ltd. · March 4, 2025
  • 483 · Shire Human Genetic Therapies, Inc. · March 23, 2022
  • 483 · CSL Behring GmbH · April 30, 2024
  • 483 · Agricultural Technology Research Institute (ATRI) · April 27, 2026
  • 483 · Astellas Pharma Inc. · July 17, 2026
  • 483 · Samsung Biologics Co., Ltd. · July 30, 2024
Frequently inspected with (10)
Wendy G. Tan
2 shared
Yun Wu
2 shared
Zhong Li
2 shared
Alan L. Truong
1 shared
Andrea Franco

Pharmaceutical Scientist

1 shared
Andrew J. Barrowcliff
1 shared
Andrew K. Haack

Compliance Officer

1 shared
Jacob G. Lutz

Investigator

1 shared
Jee Y. Chung

issuing_officer

1 shared
Khalid M. Khan
1 shared
Person Information

Name

Charles Y. Kuo

Title

issuing_officer

Role

COMPANY REP

ID: 36d44416-c980-4b33-b62e-ea0761a46a46

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