Andrea George
FDA investigator
Appears on 2 documents from 2019 to 2022, mostly at sites in California. Most often cites written procedures; deviations (21 CFR 211.100).
- 2
- Documents on file
- 3.0
- Observations per 483
- 2019
- First seen
- 2022
- Most recent
What they cite most
From 6 observations- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.67Equipment cleaning and maintenance1
- 21 CFR 601.12Changes to an approved application1
Activity by year
2019: 1, 2022: 1
Where
California 1 · Puerto Rico 1
Often inspects with
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Inspection history
2 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2022-05-26 | 483 Genentech, Inc.May 26, 2022 · South San Francisco, California | South San Francisco, California | 2 | |
| 2019-05-08 | 483 Amgen Manufacturing Limited LLCMay 8, 2019 · Juncos, Puerto Rico | Juncos, Puerto Rico | 4 |
About this profile
What does Andrea George inspect?
Andrea George appears on 2 documents on file covering 2 sites, mostly in California.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 211.113 and 21 CFR 211.160.
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 Andrea George is dated May 26, 2022.