Steven E. Bowen
FDA investigator
Appears on 6 documents from 2019 to 2024, most often at sites in Israel. Most often cites design and construction features (21 CFR 211.42).
- 6
- Documents on file
- 6.2
- Observations per 483
- 2019
- First seen
- 2024
- Most recent
What they cite most
From 37 observations- 21 CFR 211.42Design and construction features6
- 21 CFR 211.100Written procedures; deviations5
- 21 CFR 211.160General requirements4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.194Laboratory records2
Activity by year
2019: 1, 2020: 4, 2024: 1
Where
Israel 2 · Texas 2 · Japan 1 · North Carolina 1
Often inspects with
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Inspection history
6 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-02-24 | 483 OMRIX BIOPHARMACEUTICALS LTDFeb 24, 2024 · RAMAT GAN, Israel | RAMAT GAN, Israel | 12 | |
| 2020-12-10 | 483 Lonza Houston, Inc.Dec 10, 2020 · Houston, Texas | Houston, Texas | 4 | |
| 2020-12-10 | 483 Lonza Houston, IncDec 10, 2020 · Houston, Texas | Houston, Texas | 4 | |
| 2020-03-05 | 483 Omrix Biopharmaceuticals LtdMar 5, 2020 · Rehovot, Israel | Rehovot, Israel | 4 | |
| 2020-01-24 | 483 Merck Teknika LLCJan 24, 2020 · Durham, North Carolina | Durham, North Carolina | 10 | |
| 2019-07-30 | 483 TOYOBO CO., LTD.Jul 30, 2019 · Otsu, Japan | Otsu, Japan | 3 |
About this profile
What does Steven E. Bowen inspect?
Steven E. Bowen appears on 6 documents on file covering 5 sites, most often in Israel.
What do they cite most often?
21 CFR 211.42 (design and construction features), followed by 21 CFR 211.100 and 21 CFR 211.160.
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 Steven E. Bowen is dated Feb 24, 2024.