James R. Birkenstamm
FDA investigator
Appears on 12 documents from 2018 to 2026, mostly at sites in New Jersey. Most often cites responsibilities of quality control unit (21 CFR 211.22).
- 12
- Documents on file
- 5.1
- Observations per 483
- 2018
- First seen
- 2026
- Most recent
What they cite most
From 61 observations- 21 CFR 211.22Responsibilities of quality control unit7
- 21 CFR 211.42Design and construction features6
- 21 CFR 211.192Production record review5
- 21 CFR 211.194Laboratory records5
- 21 CFR 211.160General requirements4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
Activity by year
2018: 2, 2019: 1, 2023: 3, 2024: 3, 2025: 2, 2026: 1
Where
New Jersey 9 · Maryland 1 · Taiwan 1 · Thailand 1
Often inspects with
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Inspection history
12 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-01-30 | 483 Safrel Pharmaceuticals LLCJan 30, 2026 · Dayton, New Jersey | Dayton, New Jersey | 10 | |
| 2025-05-21 | 483 Acino Products, LLCMay 21, 2025 · Hamilton, New Jersey | Hamilton, New Jersey | 3 | |
| 2025-03-24 | 483 Tulex Pharmaceuticals IncMar 24, 2025 · Cranbury, New Jersey | Cranbury, New Jersey | 2 | |
| 2024-10-15 | 483 Health and Natural Beauty USA CorpOct 15, 2024 · Piscataway, New Jersey | Piscataway, New Jersey | 4 | |
| 2024-05-31 | 483 AstraZeneca Pharmaceuticals LPMay 31, 2024 · Gaithersburg, Maryland | Gaithersburg, Maryland | 4 | |
| 2024-04-02 | 483 Nang Kuang Pharmaceutical Co. Ltd.Apr 2, 2024 · Tainan City, Taiwan | Tainan City, Taiwan | 6 | |
| 2023-07-21 | 483 S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED BRANCHJul 21, 2023 · SI RACHA, Thailand | SI RACHA, Thailand | 3 |
About this profile
What does James R. Birkenstamm inspect?
James R. Birkenstamm appears on 12 documents on file covering 12 sites, mostly in New Jersey.
What do they cite most often?
21 CFR 211.22 (responsibilities of quality control unit), followed by 21 CFR 211.42 and 21 CFR 211.192.
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for James R. Birkenstamm is dated Jan 30, 2026.