Anna Kwilas
FDA investigator
Appears on 3 documents from 2022 to 2024, mostly at sites in Pennsylvania. Most often cites production record review (21 CFR 211.192).
- 3
- Documents on file
- 4.7
- Observations per 483
- 2022
- First seen
- 2024
- Most recent
What they cite most
From 14 observations- 21 CFR 211.192Production record review4
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures3
- 21 CFR 211.160General requirements2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.180General requirements1
Activity by year
2022: 1, 2024: 2
Where
Pennsylvania 2 · North Carolina 1
Often inspects with
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-04-05 | 483 Adaptimmune LLCApr 5, 2024 · Philadelphia, Pennsylvania | Philadelphia, Pennsylvania | 5 | |
| 2024-02-16 | 483 RTP Operating, LLCFeb 16, 2024 · Durham, North Carolina | Durham, North Carolina | 5 | |
| 2022-11-16 | 483 Krystal Biotech, Inc.Nov 16, 2022 · Pittsburgh, Pennsylvania | Pittsburgh, Pennsylvania | 4 |
About this profile
What does Anna Kwilas inspect?
Anna Kwilas appears on 3 documents on file covering 3 sites, mostly in Pennsylvania.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.84 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 Anna Kwilas is dated Apr 5, 2024.