Michael A. Charles
FDA investigator · also recorded as Ems Michael A. Charles, Ae Michael A. Charles
Appears on 29 documents from 2013 to 2024, most often at sites in Colorado. Most often cites production record review (21 CFR 211.192).
- 29
- Documents on file
- 4.1
- Observations per 483
- 2013
- First seen
- 2024
- Most recent
What they cite most
From 117 observations- 21 CFR 211.192Production record review19
- 21 CFR 211.160General requirements15
- 21 CFR 211.42Design and construction features15
- 21 CFR 211.67Equipment cleaning and maintenance14
- 21 CFR 211.113Control of microbiological contamination8
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures7
Activity by year
2013: 1, 2014: 1, 2015: 2, 2018: 3, 2019: 5, 2020: 3, 2021: 6, 2022: 5, 2023: 1, 2024: 2
Where
Colorado 8 · India 7 · China 4 · New Mexico 2 · Arizona 1 · Egypt 1
Often inspects with
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Inspection history
29 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-09-27 | 483 Taixing SynTheAll Pharmaceutical Co., LtdSep 27, 2024 · Taixing, China | Taixing, China | 5 | |
| 2024-05-17 | 483 DR.REDDY'S LABORATORIES LIMITEDMay 17, 2024 · Visakhapatnam, India | Visakhapatnam, India | 2 | |
| 2023-01-27 | 483 RUBICON RESEARCH LIMITEDJan 27, 2023 · Satara, India | Satara, India | 3 | |
| 2022-11-10 | 483 Pharmaplast SAENov 10, 2022 · Alexandria, Egypt | Alexandria, Egypt | 7 | |
| 2022-09-29 | 483 Zydus Animal Health and Investments LimitedSep 29, 2022 · AHMEDABAD, India | AHMEDABAD, India | — | |
| 2022-09-21 | 483 CIRON DRUGS AND PHARMACEUTICALS PVT LTDSep 21, 2022 · Tarapur, India | Tarapur, India | 4 | |
| 2022-08-05 | 483 F. Hoffmann-La Roche LtdAug 5, 2022 · Kaiseraugst, Switzerland | Kaiseraugst, Switzerland | 3 |
About this profile
What does Michael A. Charles inspect?
Michael A. Charles appears on 29 documents on file covering 28 sites, most often in Colorado.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.160 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 A. Charles is dated Sep 27, 2024.