Janet L. Bowen
FDA investigator · also recorded as Eae Janet L. Bowen
Appears on 4 documents from 2015 to 2021, mostly at sites in Massachusetts. Most often cites design and construction features (21 CFR 211.42).
- 4
- Documents on file
- 8.3
- Observations per 483
- 2015
- First seen
- 2021
- Most recent
What they cite most
From 33 observations- 21 CFR 211.42Design and construction features5
- 21 CFR 211.192Production record review4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.188Batch production and control records3
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.100Written procedures; deviations2
Activity by year
2015: 1, 2019: 2, 2021: 1
Where
Massachusetts 2 · Michigan 1 · Ohio 1
Often inspects with
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Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2021-05-20 | 483 Pharmacia & Upjohn Company LLCMay 20, 2021 · Kalamazoo, Michigan | Kalamazoo, Michigan | 4 | |
| 2019-12-13 | 483 Rentschler Biopharma Inc.Dec 13, 2019 · Milford, Massachusetts | Milford, Massachusetts | 9 | |
| 2019-11-19 | 483 MassBiologicsNov 19, 2019 · Boston, Massachusetts | Boston, Massachusetts | 11 | |
| 2015-09-14 | 483 RC Compounding Services, LLCSep 14, 2015 · Poland, Ohio | Poland, Ohio | 9 |
About this profile
What does Janet L. Bowen inspect?
Janet L. Bowen appears on 4 documents on file covering 4 sites, mostly in Massachusetts.
What do they cite most often?
21 CFR 211.42 (design and construction features), followed by 21 CFR 211.192 and 21 CFR 211.113.
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 Janet L. Bowen is dated May 20, 2021.