Michael R. Shanks
FDA investigator
Appears on 27 documents from 2017 to 2024, most often at sites in California. Most often cites control of microbiological contamination (21 CFR 211.113).
- 27
- Documents on file
- 3.1
- Observations per 483
- 2017
- First seen
- 2024
- Most recent
What they cite most
From 82 observations- 21 CFR 211.113Control of microbiological contamination21
- 21 CFR 211.22Responsibilities of quality control unit11
- 21 CFR 211.42Design and construction features10
- 21 CFR 211.68Automatic, mechanical, and electronic equipment7
- 21 CFR 211.100Written procedures; deviations6
- 21 CFR 211.67Equipment cleaning and maintenance6
Activity by year
2017: 1, 2018: 3, 2019: 4, 2020: 1, 2021: 4, 2022: 7, 2023: 5, 2024: 2
Where
California 5 · India 5 · Germany 2 · Indiana 2 · Italy 2 · South Korea 2
Often inspects with
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Inspection history
27 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-03-08 | 483 BioConnection B.V.Mar 8, 2024 · Oss, Netherlands | Oss, Netherlands | 2 | |
| 2024-01-19 | 483 Alvotech HfJan 19, 2024 · Reykjavik, Iceland | Reykjavik, Iceland | 1 | |
| 2023-10-17 | 483 Patheon Biologics Australia Pty LtdOct 17, 2023 · Woolloongabba, Australia | Woolloongabba, Australia | 2 | |
| 2023-03-10 | 483 Roche Diagnostics GmbHMar 10, 2023 · Penzberg, Germany | Penzberg, Germany | 2 | |
| 2023-02-02 | 483 Genentech, Inc.Feb 2, 2023 · South San Francisco, California | South San Francisco, California | 4 | |
| 2023-01-24 | 483 Tanvex BioPharma USA, IncJan 24, 2023 · San Diego, California | San Diego, California | 3 | |
| 2023-01-16 | 483 Form 483 · FEI 3004575449Jan 16, 2023 · San Diego, California | San Diego, California | 3 |
About this profile
What does Michael R. Shanks inspect?
Michael R. Shanks appears on 27 documents on file covering 23 sites, most often in California.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.22 and 21 CFR 211.42.
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 Michael R. Shanks is dated Mar 8, 2024.