FDA Person
FDAShirley S. Wen
View detailed information about Shirley S. Wen, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 61 inspections of 58 companies, 2016–2026.
Inspections (61)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| September 3, 2026 | RECENSMEDICAL INC | Not classified | Compliance: Devices | #1337210 |
| August 20, 2026 | Jiangsu Kangbao Medical Equipment Co., Ltd. | Not classified | #1339452 | |
| June 25, 2026 | Vynacron Dental Resins, Inc. | Not classified | Compliance: Devices | #1325156 |
| May 18, 2026 | Burpee Materials Technology, LLC | Not classified | #1321152 | |
| May 1, 2026 | Curio Digital Therapeutics Inc. | Not classified | #1317058 | |
| April 6, 2026 | Nano-Ditech Corporation | Not classified | #1313410 | |
| March 6, 2026 | Perma Pure LLC | NAI | Compliance: Devices | #1309030 |
| February 10, 2026 | Microcision Llc | Not classified | #1305868 | |
| December 8, 2025 | Healgen Scientific LLC | NAI | Compliance: Devices | #1296424 |
| September 30, 2025 | Keystone Industries | NAI | Postmarket Assurance: Medical Devices | #1284796 |
| August 22, 2025 | Rhythmedix | Not classified | #1280924 | |
| April 7, 2025 | Cetylite Industries, Inc. | NAI | Postmarket Assurance: Medical Devices | #1266077 |
| February 10, 2025 | SENSONICS, INTERNATIONAL | NAI | Postmarket Assurance: Medical Devices | #1260488 |
| January 21, 2025 | Vynacron Dental Resins, Inc. | OAI | Compliance: Medical Devices | #1259194 |
| August 22, 2024 | Integra LifeSciences Corporation | OAI | Compliance: Devices | #1237437 |
| August 22, 2024 | Integra LifeSciences Corp. | OAI | Compliance: Devices | #1235661 |
| March 4, 2024 | Vineland Syrup Inc. | NAI | Postmarket Assurance: Devices | #1231771 |
| January 8, 2024 | Integrity Medical Devices Inc. | VAI | Compliance: Devices | #1230337 |
| December 1, 2023 | Howmedica Osteonics Corp. | VAI | Compliance: Devices | #1223869 |
| August 18, 2023 | UltraRad Corporation | NAI | Postmarket Assurance: Devices | #1222755 |
Documents (27)
- EIR · Aquestive Therapeutics Inc. · October 7, 2021
- EIR · Clario (BioClinica, Inc.) · February 5, 2021
- 483 · Vynacron Dental Resins, Inc. · January 21, 2025
- 483 · SENSONICS, INTERNATIONAL · February 10, 2025
- 483 · Cetylite Industries, Inc. · April 7, 2025
- 483 · Merck & Co. Inc · August 26, 2016
- 483 · Integrity Medical Devices Inc. · January 8, 2024
- EIR · Bristol Myers Squibb · April 22, 2020
- EIR · BioClinica, Inc. · May 12, 2022
- EIR · Sanofi US Services, Inc. · October 9, 2018
- EIR · APCER Life Sciences, Inc. · June 21, 2016
- 483 · Deborah Heart & Lung Center IRB · July 26, 2021
- 483 · Sanofi US · August 3, 2016
- 483 · Validus Pharmaceuticals, Inc. · November 13, 2019
- 483 · Fosun Pharma USA Inc. · August 17, 2021
- 483 · Novartis Pharmaceuticals Corporation · July 2, 2019
- EIR · Janssen Research & Development, LLC · February 4, 2019
- 483 · Sterigenics US LLC · May 31, 2023
- 483 · Braeburn Pharmaceuticals Inc. · February 8, 2018
- 483 · Bi-Coastal Pharma International · September 14, 2020
- 483 · Aquestive Therapeutics Inc. · October 7, 2021
- 483 · FOAMIX PHARMACEUTICALS, INC. · April 24, 2019
- EIR · Allergan Sales, LLC · June 6, 2019
- EIR · Fosun Pharma USA Inc. · August 17, 2021
- EIR · Daniel P. Petrylak, M.D. · September 20, 2019
- 483 · Deborah Heart & Lung Center IRB · July 26, 2026
- EIR · David R. Hassman, DO · September 27, 2017
Frequently inspected with (10)
Nina Yang
investigator
8 shared
Michael Serrano
investigator
7 shared
Frank J. Marciniak
4 shared
Byungja E. Marciante
3 shared
Bei Yu
issuing_officer
2 shared
Matthew W. Kyle
issuing_officer
2 shared
Adetutu M. Gidado
1 shared
Anastasia I. Onuorah
investigator
1 shared
Barbara J. Maulfair
investigator
1 shared
Jaro P. Perera
1 shared
Person Information
Name
Shirley S. Wen
Role
ISSUING OFFICER
ID: eafbc8e5-a0ac-443a-adaf-ced505f77842
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