FDA Person
FDAWalden H. Lee
View detailed information about Walden H. Lee, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 41 inspections of 36 companies, 2017–2026.
Inspections (41)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| August 25, 2026 | PIOUS LABORATORIES PRIVATE LIMITED | Not classified | #1338748 | |
| June 17, 2026 | Jubilant HollisterStier LLC | Not classified | Drug Quality Assurance | #1303204 |
| May 18, 2026 | LGM Pharma Solutions, LLC | Not classified | Drug Quality Assurance | #1317740 |
| April 29, 2026 | Samson Pharmaceuticals, Inc | Not classified | Drug Quality Assurance | #1314718 |
| March 26, 2026 | Genesis Alkali LLC | Not classified | #1293906 | |
| February 13, 2026 | K.C. Pharmaceuticals, Inc | Not classified | Drug Quality Assurance | #1294070 |
| November 21, 2025 | B. Braun Medical Inc | OAI | Drug Quality Assurance | #1292536 |
| September 10, 2025 | AMPAC Fine Chemicals, LLC dba AMPAC Analytical | Not classified | #1282758 | |
| April 28, 2025 | McGuff Pharmaceuticals, Inc. | OAI | Drug Quality Assurance | #1268175 |
| March 5, 2025 | Compounders International Analytical Laboratory | OAI | Drug Quality Assurance | #1263374 |
| February 7, 2025 | Hospira, Inc. | Not classified | #1251941 | |
| September 25, 2024 | Mentha & Allied Products Private Ltd. | OAI | Drug Quality Assurance | #1252693 |
| September 12, 2024 | Shree Jaya Laboratories Private Limited | OAI | Drug Quality Assurance | #1249117 |
| June 28, 2024 | Bachem Americas, Inc. | VAI | Monitoring of Marketed Animal Drugs, Feed, and Devices | #1244716 |
| June 6, 2024 | Jubilant HollisterStier LLC | Not classified | Drug Quality Assurance | #1230373 |
| May 10, 2024 | PolyPeptide Laboratories, Inc. | VAI | Monitoring of Marketed Animal Drugs, Feed, and Devices | #1246171 |
| March 20, 2024 | Genentech, Inc. | NAI | Drug Quality Assurance | #1235655 |
| March 1, 2024 | Amphastar Pharmaceuticals, Inc. | VAI | Drug Quality Assurance | #1229403 |
| February 9, 2024 | Nephron Sc Inc | OAI | Drug Quality Assurance | #1229051 |
| December 18, 2023 | Med-Pharmex, Inc. | OAI | Monitoring of Marketed Animal Drugs, Feed, and Devices | #1226130 |
Documents (33)
- EIR · Bachem Americas, Inc. · February 10, 2017
- 483 · Impax Laboratories, LLC. · February 28, 2013
- 483 RESPONSE · Stokes Healthcare Inc. dba Epicur Pharma · February 12, 2016
- 483 · Emcure Pharmaceuticals Limited · February 20, 2019
- 483 · Stason Pharmaceuticals, Inc. · October 25, 2019
- 483 · Bachem Americas, Inc. · February 10, 2017
- EIR · Gilead Sciences, Inc. · July 25, 2014
- 483 · Jubilant HollisterStier LLC · June 6, 2024
- 483 · B. Braun Medical Inc · November 21, 2025
- 483 · University of Southern California, DBA USC Molecular Imaging Center · August 14, 2019
- 483 · Teva Parenteral Medicines, Inc. · August 20, 2021
- 483 · Med-Pharmex, Inc. · September 14, 2021
- 483 · B. Braun Medical Inc · July 23, 2020
- 483 · Compounders International Analytical Laboratory · March 5, 2025
- 483 · McGuff Pharmaceuticals, Inc. · April 28, 2025
- 483 · Amphastar Pharmaceuticals, Inc. · March 1, 2024
- 483 · Taro Pharmaceutical Industries, Ltd. · July 11, 2019
- 483 · Cipla Ltd. · January 20, 2020
- 483 · Teva Parenteral Medicines, Inc. · January 18, 2019
- 483 · Med-Pharmex, Inc. · May 17, 2019
- 483 · Nanoimaging Services, Inc. · March 3, 2022
- 483 · Eugia SEZ Private Limited · March 1, 2019
- 483 · Mentha & Allied Products Private Ltd. · September 25, 2024
- 483 · B. Braun Medical Inc · June 29, 2018
- 483 · Adamson Analytical Laboratories, Inc. · March 23, 2021
- 483 · Med-Pharmex, Inc. · December 18, 2023
- 483 · PolyPeptide Laboratories, Inc. · May 10, 2024
- 483 · Front Range Laboratories, Incorporated · March 20, 2020
- 483 · Jubilant HollisterStier LLC · June 17, 2026
- 483 · Chromatography Institute of America, Inc. · May 5, 2023
- 483 · K.C. Pharmaceuticals, Inc · February 13, 2026
- 483 · Samson Pharmaceuticals, Inc · April 29, 2026
- 483 · LGM Pharma Solutions, LLC · May 18, 2026
Frequently inspected with (10)
Amanda L. Fyles
investigator
6 shared
Amir Alavi
investigator
3 shared
Carrie A. Hughes
3 shared
Cecilia H. Kieu
3 shared
Homero W. Aguilar
3 shared
Jay-Ar C. Bendo
3 shared
Jennifer M. Gogley
Laboratory Director
3 shared
Jessica P. Mcalister
Pharmacy Compounding National Expert at FDA
3 shared
Joey V. Quitania
Public Affairs Specialist
3 shared
Linda Thai
Team Biologics Staff
3 shared
Person Information
Name
Walden H. Lee
Title
Chemist/Investigator - Pharmaceutical Quality
Role
Regulatory Personnel
ID: 18131eea-d1cb-47c4-af79-bea22d436031
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