FDA Person
FDAJames R. Birkenstamm
View detailed information about James R. Birkenstamm, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 59 inspections of 53 companies, 2016–2026.
Inspections (59)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| September 24, 2026 | Indivior UK Limited | Not classified | #1343906 | |
| September 18, 2026 | MW Encap Ltd.(NextPharma Edinburgh) | Not classified | Drug Quality Assurance | #1336234 |
| September 11, 2026 | Ferring Controlled Therapeutics, Ltd. | Not classified | #1345014 | |
| June 4, 2026 | Aurobindo Pharma USA Inc | Not classified | #1316082 | |
| May 14, 2026 | Appco Pharma LLC | Not classified | Drug Quality Assurance | #1301504 |
| March 30, 2026 | ZivaQ Pharmaceuticals Inc. | Not classified | Foodborne Biological Hazards | #1306270 |
| January 30, 2026 | Safrel Pharmaceuticals LLC | Not classified | #1300468 | |
| November 21, 2025 | Tris Pharma Inc. | VAI | Drug Quality Assurance | #1289086 |
| July 21, 2025 | E-Beam Services, Inc. | Not classified | #1277036 | |
| June 18, 2025 | TPM Laboratories, Inc. | NAI | Drug Quality Assurance | #1275853 |
| June 2, 2025 | STRIVE PHARMACEUTICALS INC | VAI | Drug Quality Assurance | #1271503 |
| May 21, 2025 | Acino Products, LLC | OAI | Drug Quality Assurance | #1270811 |
| March 24, 2025 | Tulex Pharmaceuticals Inc. | VAI | Drug Quality Assurance | #1264812 |
| February 28, 2025 | SciSafe, Inc. | Not classified | #1265039 | |
| January 17, 2025 | ENDO Pharmaceuticals Solutions, Inc. | VAI | Drug Quality Assurance | #1258791 |
| November 20, 2024 | N-Molecular Inc. d.b.a. SOFIE | VAI | Drug Quality Assurance | #1250020 |
| October 15, 2024 | Health And Natural Beauty USA Corp | OAI | Drug Quality Assurance | #1251733 |
| May 31, 2024 | AstraZeneca Pharmaceuticals LP | VAI | Drug Quality Assurance | #1238346 |
| April 12, 2024 | Lotus Pharmaceutical Co., Ltd. | VAI | Drug Quality Assurance | #1236763 |
| April 2, 2024 | Nang Kuang Pharmaceutical Co., Ltd. | OAI | Drug Quality Assurance | #1236762 |
Documents (26)
- 483 RESPONSE · N-Molecular Inc. d.b.a. SOFIE · November 7, 2024
- EIR · N-Molecular Inc. d.b.a. SOFIE · November 20, 2024
- 483 · Premier Trends LLC · June 28, 2019
- 483 · Ohm Laboratories Inc. · February 5, 2020
- 483 · Tris Pharma Inc. · November 21, 2025
- 483 · ENDO Pharmaceuticals Solutions, Inc. · January 17, 2025
- 483 · STRIVE PHARMACEUTICALS INC · June 2, 2025
- 483 · Tulex Pharmaceuticals Inc. · March 24, 2025
- 483 · Acino Products, LLC · May 21, 2025
- 483 · Aurohealth LLC · April 11, 2019
- 483 · Nang Kuang Pharmaceutical Co., Ltd. · April 2, 2024
- 483 · Scientech Laboratories Inc · April 25, 2017
- 483 · Primera Analytical Solutions Corp. · November 20, 2018
- 483 · InvaDerm, Inc. · June 28, 2023
- 483 · DuPont Nutrition USA, Inc · October 25, 2023
- 483 · AstraZeneca Pharmaceuticals LP · May 31, 2024
- 483 · Cetylite Industries, Inc. · March 2, 2023
- 483 · Spectrum Laboratory Products, Inc. · July 14, 2021
- EIR · Alcami Corporation · March 19, 2018
- 483 · Health And Natural Beauty USA Corp · October 15, 2024
- 483 · S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED · July 21, 2023
- 483 · Eugia US Manufacturing LLC · December 22, 2023
- 483 · Appco Pharma LLC · November 6, 2018
- 483 · N-Molecular Inc. d.b.a. SOFIE · November 20, 2024
- 483 · Safrel Pharmaceuticals LLC · January 30, 2026
- 483 · Thai Nakorn Patana Co., Ltd, · August 4, 2023
Frequently inspected with (10)
Person Information
Name
James R. Birkenstamm
Role
ISSUING OFFICER
ID: eb1192a4-3c76-4243-886c-9b5805871ad1
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