Alice S. Tsao
FDA investigator
Appears on 16 documents from 2011 to 2023, mostly at sites in New York. Most often cites equipment cleaning and maintenance (21 CFR 211.67).
- 16
- Documents on file
- 5.0
- Observations per 483
- 2011
- First seen
- 2023
- Most recent
What they cite most
From 80 observations- 21 CFR 211.67Equipment cleaning and maintenance9
- 21 CFR 211.160General requirements8
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products7
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.100(a)Written procedures; deviations4
- 21 CFR 211.166Stability testing4
Activity by year
2011: 2, 2014: 1, 2015: 2, 2016: 4, 2017: 1, 2019: 3, 2023: 3
Where
New York 12 · New Jersey 2 · Belgium 1 · Pennsylvania 1
Often inspects with
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Inspection history
16 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-08-29 | 483 APPCO PHARMA LLCAug 29, 2023 · Piscataway, New Jersey | Piscataway, New Jersey | 3 | |
| 2023-04-21 | 483 UCB Pharma SA, Braine Chemin du ForiestApr 21, 2023 · Braine-l’Alleud, Belgium | Braine-l’Alleud, Belgium | 2 | |
| 2023-03-17 | 483 FORDOZ PHARMA CORPORATIONMar 17, 2023 · East Windsor, New Jersey | East Windsor, New Jersey | 4 | |
| 2019-03-29 | 483 ARx, LLCMar 29, 2019 · Glen Rock, Pennsylvania | Glen Rock, Pennsylvania | 9 | |
| 2019-03-18 | 483 Amneal Pharmaceuticals of New York, LLCMar 18, 2019 · Hauppauge, New York | Hauppauge, New York | 1 | |
| 2019-02-01 | 483 Epic Pharma, LLCFeb 1, 2019 · Laurelton, New York | Laurelton, New York | 6 | |
| 2017-01-30 | 483 MasterPharm LLCJan 30, 2017 · Richmond Hill, New York | Richmond Hill, New York | 2 |
About this profile
What does Alice S. Tsao inspect?
Alice S. Tsao appears on 16 documents on file covering 16 sites, mostly in New York.
What do they cite most often?
21 CFR 211.67 (equipment cleaning and maintenance), followed by 21 CFR 211.160 and 21 CFR 211.110(a).
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 Alice S. Tsao is dated Aug 29, 2023.