Ana P. Sandee
FDA investigator
Appears on 6 documents from 2019 to 2020, mostly at sites in Missouri. Most often cites responsibilities of quality control unit (21 CFR 211.22).
- 6
- Documents on file
- 4.2
- Observations per 483
- 2019
- First seen
- 2020
- Most recent
What they cite most
From 25 observations- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
- 21 CFR 211.192Production record review3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.160General requirements2
Activity by year
2019: 4, 2020: 2
Where
Missouri 3 · Wisconsin 2 · Kansas 1
Often inspects with
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Inspection history
6 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2020-02-28 | 483 Sparhawk Laboratories, Inc.Feb 28, 2020 · Lenexa, Kansas | Lenexa, Kansas | 6 | |
| 2020-01-16 | 483 Apertus Pharmaceuticals, LLCJan 16, 2020 · Ballwin, Missouri | Ballwin, Missouri | 5 | |
| 2019-07-25 | 483 MaxPax, LLCJul 25, 2019 · Elkhorn, Wisconsin | Elkhorn, Wisconsin | 2 | |
| 2019-07-25 | 483 MaxPax, LLCJul 25, 2019 · Elkhorn, Wisconsin | Elkhorn, Wisconsin | 2 | |
| 2019-05-31 | 483 Nesher Pharmaceuticals (USA) LLCMay 31, 2019 · Bridgeton, Missouri | Bridgeton, Missouri | 8 | |
| 2019-02-06 | 483 Sigma-Aldrich Manufacturing LLCFeb 6, 2019 · Saint Louis, Missouri | Saint Louis, Missouri | 2 |
About this profile
What does Ana P. Sandee inspect?
Ana P. Sandee appears on 6 documents on file covering 6 sites, mostly in Missouri.
What do they cite most often?
21 CFR 211.22 (responsibilities of quality control unit), followed by 21 CFR 211.68 and 21 CFR 211.192.
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 Ana P. Sandee is dated Feb 28, 2020.