FDA Person
FDAJie He
View detailed information about Jie He, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 13 inspections of 13 companies, 2017–2026.
Inspections (13)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| May 20, 2026 | Shanghai Henlius Biopharmaceuticals Co., Ltd. | Not classified | #1320008 | |
| December 15, 2025 | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (FDF Site) | Not classified | #1295788 | |
| May 20, 2025 | Eli Lilly & Company | VAI | Drug Quality Assurance | #1270621 |
| March 11, 2025 | FUJIFILM Diosynth Biotechnologies Texas, LLC | Not classified | #1268686 | |
| January 30, 2025 | Allergan Pharmaceuticals Ireland | Not classified | #1259046 | |
| November 25, 2024 | VGXI, Inc. | Not classified | #1259896 | |
| July 12, 2024 | Lonza Netherlands B.V. | Not classified | #1246026 | |
| February 16, 2024 | Oxford Biomedica (US), LLC | Not classified | #1232586 | |
| November 10, 2023 | Wyeth Pharmaceutical Division of Wyeth Holdings LLC | Not classified | #1234989 | |
| January 20, 2023 | Berkshire Sterile Manufacturing, LLC | VAI | Blood and Blood Products | #1202788 |
| December 18, 2018 | Sanofi Winthrop Industrie | Not classified | #1076287 | |
| December 10, 2018 | Sanofi Winthrop Industrie | Not classified | #1080126 | |
| November 21, 2017 | Prometic Bioproduction Inc. | Not classified | #1140884 |
Documents (10)
- 483 · Bio-Thera Solutions, Ltd. · October 6, 2017
- 483 · FUJIFILM Diosynth Biotechnologies Texas, LLC · March 11, 2025
- 483 · Eli Lilly & Company · May 20, 2025
- 483 · Allergan Pharmaceuticals Ireland · January 30, 2025
- 483 · Oxford Biomedica (US), LLC
- 483 · Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (FDF Site) · December 15, 2025
- 483 · Resilience Biotechnologies, Inc. · February 7, 2020
- 483 · Berkshire Sterile Manufacturing, LLC · January 20, 2023
- 483 · Bio-Thera Solutions, Ltd. · September 26, 2025
- 483 · Shanghai Henlius Biopharmaceuticals Co., Ltd. · May 20, 2026
Frequently inspected with (10)
Carl A. Perez
2 shared
Debra M. Emerson
Strategic Expert at NovoNordisk; Retired from FDA
2 shared
Sharmila Shrestha
2 shared
Zhong Li
2 shared
Alexey Khrenov
investigator
1 shared
Alifiya H. Ghadiali
1 shared
Anna R. Kwilas
investigator
1 shared
Ayyappan Rathakrishnan
1 shared
Dino A. Feigelstock
1 shared
Graeme E. Price
1 shared
Person Information
Name
Jie He
Role
ISSUING OFFICER
ID: 162aef4b-4b22-48e5-9a50-9b2e9684d589
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