FDA Person
FDALinda Thai
View detailed information about Linda Thai, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 41 inspections of 40 companies, 2016–2026.
Inspections (41)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| June 11, 2026 | CA Analytical Testing Services LLC | Not classified | #1325028 | |
| May 22, 2026 | PETNET SOLUTIONS, INC. | Not classified | New Drug Evaluation | #1318434 |
| January 16, 2026 | Novartis Manufacturing LLC | Not classified | #1301300 | |
| September 26, 2025 | Everlight Chemical Industrial Corporation Kuanyin II Plant | VAI | Drug Quality Assurance | #1292578 |
| September 19, 2025 | Syn-Tech Chemical & Pharm. Co., Ltd. | Not classified | #1290872 | |
| September 12, 2025 | Swiss Pharmaceutical Company Ltd | Not classified | #1288280 | |
| May 29, 2025 | Avid Bioservices Inc. | NAI | Drug Quality Assurance | #1272594 |
| May 1, 2025 | Revance Therapeutics, Inc. | NAI | Drug Quality Assurance | #1269921 |
| February 27, 2025 | ABC Pharmaceuticals | VAI | Drug Quality Assurance | #1262486 |
| September 27, 2024 | Kolmask Co., Ltd. | VAI | Drug Quality Assurance | #1254238 |
| September 20, 2024 | Kyowa Hakko Bio Co., Ltd. | NAI | Drug Quality Assurance | #1253956 |
| September 13, 2024 | CMIC CMO Co., Ltd. Nishine Plant | Not classified | #1253045 | |
| August 30, 2024 | Anesta LLC | VAI | Generic Drug Evaluation | #1248477 |
| June 28, 2024 | Bachem Americas, Inc. | VAI | Monitoring of Marketed Animal Drugs, Feed, and Devices | #1244716 |
| September 20, 2019 | Merck Sharp & Dohme LLC | VAI | Vaccines and Allergenic Products | #1103540 |
| August 1, 2019 | Southern California Compounding Pharmacy, LLC | VAI | Drug Quality Assurance | #1099870 |
| May 31, 2019 | IDT Australia Ltd. | VAI | Pre-Approval Eval. of Animal Drugs and Food Additives | #1093403 |
| May 15, 2019 | Greenstone Pharmaceutical HK Inc. | NAI | Drug Quality Assurance | #1093402 |
| April 25, 2019 | Constant Irwindale, Inc. | VAI | Monitoring of Marketed Animal Drugs, Feed, and Devices | #1092110 |
| March 22, 2019 | Ajinomoto Althea, Inc. | Not classified | #1088015 |
Documents (35)
- 483 · California Pharmacy & Compounding Center · December 17, 2018
- 483 · University Rx Specialist, dba University Compounding Pharmacy · September 21, 2015
- 483 · California Pharmacy & Compounding Center · August 31, 2016
- EIR · SAFC Carlsbad Inc. · December 16, 2021
- AMENDED 483 · California Pharmacy & Compounding Center · December 7, 2018
- 483 · Zions Rx Formulations Services LLC dba Rx Formuations Serv. · January 9, 2014
- 483 · Revance Therapeutics, Inc. · February 27, 2025
- 483 · ABC Pharmaceuticals · February 27, 2025
- 483 · Emergent Biodefense Operations Lansing LLC · September 29, 2021
- 483 · Emergent BioSolutions Canada Inc. · May 10, 2022
- EIR · Intercept Pharmaceuticals · February 1, 2016
- 483 · Merck Sharp & Dohme LLC · September 9, 2019
- 483 · Ajinomoto Althea, Inc. · March 18, 2019
- 483 · University of Massachusetts Incorporated · November 1, 2022
- 483 · American Regent, Inc. · January 25, 2019
- 483 · Intercept Pharmaceuticals · February 1, 2016
- 483 · Genentech, Inc. · October 18, 2017
- 483 · ID Biomedical Corporation of Quebec · May 20, 2022
- 483 · SAFC Carlsbad Inc. · December 16, 2021
- 483 · Emergent BioSolutions Canada Inc. · May 10, 2022
- 483 · Kolmask Co., Ltd. · September 27, 2024
- 483 · Baxalta US Inc. · April 7, 2022
- 483 · Novacyl Roussillon · July 4, 2014
- 483 · Novartis Gene Therapies, Inc. · August 23, 2021
- 483 · Grifols Diagnostic Solutions Inc. · February 17, 2022
- 483 · Alliance Medical Products, Inc. DBA Siegfried Company · May 26, 2017
- 483 · Merck Sharp & Dohme LLC
- 483 · Anesta LLC · August 30, 2024
- EIR · Ajinomoto Althea, Inc. · March 22, 2019
- 483 · Syn-Tech Chemical & Pharm. Co., Ltd. · September 19, 2025
- 483 · PETNET SOLUTIONS, INC. · May 22, 2026
- EIR · Bristol-Myers Squibb Company · February 19, 2021
- EIR · Alliance Medical Products, Inc. DBA Siegfried Company · May 26, 2017
- 483 · Bayer HealthCare, LLC · November 13, 2019
- EIR · Merck Sharp & Dohme LLC · September 20, 2019
Frequently inspected with (10)
Walden H. Lee
Chemist/Investigator - Pharmaceutical Quality
3 shared
Amanda L. Fyles
investigator
2 shared
Gavin T. Cua
issuing_officer
2 shared
Gunneet Kaur
Stryker, Regulatory Affairs
2 shared
Sparky L. Bartee
2 shared
Anissa M. Cheung
1 shared
Anney Lin
Statistical Science Director
1 shared
Ashar P. Parikh
1 shared
Ashley N. Queen
Microbiologist
1 shared
Cecilia H. Kieu
1 shared
Person Information
Name
Linda Thai
Title
Team Biologics Staff
Role
Regulatory Personnel
ID: f4d9a1c3-e5e8-4f13-8abe-e1f1e597c8f8
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