Overview
- 68 inspections across 58 sites are on record.
- 209 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2026-05-14.
At a glance
Inspections
68
Sites
58
Observations
209
Career since
Aug 2016
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| 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 → |
| E-Beam Services, Inc. | 21 Jul 2025 | Human Drugs |
Sites inspected
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.
E-Beam Services, Inc.Cranbury, 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
Maria Estrella1 shared
Amatul H Marium1 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