FDA Person
Department of Health and Human ServicesJay B. Shah
View detailed information about Jay B. Shah, including compliance records, violations, and related data.
Person Profile
FDA investigator, Department of Health and Human Services. Took part in 42 inspections of 41 companies, 2024–2026.
Inspections (42)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| September 29, 2026 | Pfizer Inc. | Not classified | Postmarket Surv. and Epidemiology | #1338628 |
| September 15, 2026 | Organon LLC | Not classified | Postmarket Surv. and Epidemiology | #1289600 |
| August 21, 2026 | Andrew J. Bauer, M.D. | Not classified | #1334202 | |
| July 30, 2026 | Clario (BioClinica, Inc.) | Not classified | #1330718 | |
| July 13, 2026 | HIKMA PHARMACEUTICALS USA INC. | VAI | Postmarket Surv. and Epidemiology | #1286008 |
| June 25, 2026 | Octapharma USA, Inc. | Not classified | #1324478 | |
| May 19, 2026 | Quagen Pharmaceuticals LLC | Not classified | #1322648 | |
| May 4, 2026 | Daiichi Sankyo, Inc. | Not classified | #1318108 | |
| April 2, 2026 | Eric B.J. Segal, M.D. | Not classified | #1313232 | |
| March 11, 2026 | Somerset Medical Center IRB | Not classified | #1306808 | |
| February 17, 2026 | BeOne Medicines USA, Inc. | VAI | Bioresearch Monitoring: Human Drugs | #1303410 |
| December 15, 2025 | Precision for Medicine | NAI | Bioresearch Monitoring | #1297604 |
| November 14, 2025 | Bogdan Batko, M.D. | Not classified | #1294146 | |
| November 7, 2025 | Prof. Petr Nemec, MUDr | NAI | Bioresearch Monitoring | #1293100 |
| October 20, 2025 | Bayer Healthcare Pharmaceuticals Inc. | Not classified | #1286004 | |
| September 9, 2025 | Teva Pharmaceuticals USA, Inc | Not classified | #1258587 | |
| August 21, 2025 | Dr. Reddy's Laboratories, Inc. | Not classified | #1280984 | |
| August 21, 2025 | Dr. Reddy's Laboratories, Inc. | NAI | Bioresearch Monitoring | #1280984 |
| July 22, 2025 | Ajanta Pharma USA Inc | VAI | Postmarketing Surveillance and Epidemiology: Human Drugs | #1276284 |
| July 2, 2025 | Newark Beth Israel Medical Center IRB | NAI | Bioresearch Monitoring | #1275656 |
Documents (19)
- 483 · Hikma Injectables USA Inc · June 8, 2022
- 483 · Ajanta Pharma USA Inc · July 22, 2025
- EIR · Janssen Pharmaceuticals, Inc · September 27, 2024
- 483 · FAR Specialty Products, Inc. · October 3, 2022
- 483 · Dipakkumar P. Pandya, M.D. · February 1, 2024
- 483 · INNOVATION LABS, INC. · July 5, 2022
- 483 · Vet Cellect Bio Products, LLC · July 9, 2021
- 483 · Laurus Generics, Inc. · January 21, 2025
- 483 · Nimesh P. Nagarsheth, M.D. · March 31, 2025
- 483 · XGen Pharmaceuticals DJB, Inc. · June 14, 2024
- 483 · Tris Pharma Inc. · June 8, 2021
- 483 · Janssen Pharmaceuticals, Inc · September 27, 2024
- 483 · MD Pharmaceutical Supply, LLC · May 9, 2022
- 483 · Aurolife Pharma, LLC · December 7, 2021
- 483 · SHUZY ROCK INC · February 14, 2022
- 483 · BeOne Medicines USA, Inc. · February 17, 2026
- 483 · Somerset Medical Center IRB · March 11, 2026
- 483 · International Trading Pharm Lab Inc · September 16, 2021
- 483 · HIKMA PHARMACEUTICALS USA INC. · July 13, 2026
Frequently inspected with (6)
Related Office
Person Information
Name
Jay B. Shah
Title
Investigator
Role
Regulatory Personnel
ID: c437fff9-807e-4dea-80c0-8f77850db6f8
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