Overview
- 69 inspections across 59 sites are on record.
- 209 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2026-06-04.
At a glance
Inspections
69
Sites
59
Observations
209
Career since
Aug 2016
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Aurobindo Pharma USA Inc | 4 Jun 2026 | Human Drugs | |
| Appco Pharma LLC | 14 May 2026 | Human Drugs | View 483 → |
| ZivaQ Pharmaceuticals Inc. | 30 Mar 2026 | Foods & Cosmetics | View 483 → |
| Safrel Pharmaceuticals LLC | 30 Jan 2026 | Foods & Cosmetics | View 483 → |
| Tris Pharma Inc. | 21 Nov 2025 | Human Drugs | View 483 → |
Sites inspected
Aurobindo Pharma USA IncEast Windsor, United States1 insp.
Appco Pharma LLCPiscataway, United States1 insp.
ZivaQ Pharmaceuticals Inc.East Brunswick, United States1 insp.
Safrel Pharmaceuticals LLCDayton, United States1 insp.
Tris Pharma Inc.Monmouth Junction, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Suchan Kim5 shared
Adetutu M Gidado4 shared
Nancy M Espinal4 shared
Ankur C Patel3 shared
Dhaval H Patel2 shared
Esteban Beltran2 shared
Nicholas A Violand2 shared
Frederick Razzaghi2 shared
Christina M Picard1 shared
Maria Estrella1 shared
Full investigator report
Get the verbatim findings behind James R Birkenstamm's 209 observations
Source 483 PDFs, verbatim observations, and how each site responded, so your team knows what they cite before they arrive.
- New inspections and Form 483s, mapped to the CFR citation
- Warning letter outcomes, and the citation patterns they repeat
- Their co-investigators, so no surprises about who shows up on site