Michele Gottshall
FDA investigator
Appears on 12 documents from 2020 to 2026, mostly at sites in Pennsylvania. Most often cites production record review (21 CFR 211.192).
- 12
- Documents on file
- 3.8
- Observations per 483
- 2020
- First seen
- 2026
- Most recent
What they cite most
From 47 observations- 21 CFR 211.192Production record review6
- 21 CFR 211.67Equipment cleaning and maintenance6
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.160General requirements3
- 21 CFR 211.165Testing and release for distribution3
Activity by year
2020: 1, 2021: 1, 2022: 3, 2023: 5, 2025: 1, 2026: 1
Where
Pennsylvania 6 · Canada 3 · Japan 2
Often inspects with
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Inspection history
12 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-02-02 | 483 B Positive National Blood Services -Feb 2, 2026 · Wyoming, Pennsylvania | Wyoming, Pennsylvania | 3 | |
| 2025-06-18 | 483 DB Biologics, LLCJun 18, 2025 | — | 1 | |
| 2023-11-10 | 483 HAMARI PFST, Ltd.Nov 10, 2023 · Hachimampara, Japan | Hachimampara, Japan | 2 | |
| 2023-10-27 | 483 Astellas Pharma Inc.Oct 27, 2023 · Yaizu, Japan | Yaizu, Japan | 1 | |
| 2023-03-03 | 483 BWXT Medical Ltd.Mar 3, 2023 · Ottawa, Canada | Ottawa, Canada | 8 | |
| 2023-02-24 | 483 Patheon Inc.Feb 24, 2023 · Mississauga, Canada | Mississauga, Canada | 1 | |
| 2023-02-17 | 483 Patheon Inc.Feb 17, 2023 · Whitby, Canada | Whitby, Canada | 1 |
About this profile
What does Michele Gottshall inspect?
Michele Gottshall appears on 12 documents on file covering 12 sites, mostly in Pennsylvania.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.67 and 21 CFR 211.22.
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 Michele Gottshall is dated Feb 2, 2026.