Louis An
FDA investigator
Appears on 1 document from 2017, mostly at sites in New Jersey. Most often cites testing and approval or rejection of components, drug product containers, and closures (21 CFR 211.84).
- 1
- Documents on file
- 12.0
- Observations per 483
- 2017
- First seen
- 2017
- Most recent
What they cite most
From 12 observations- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures3
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
Activity by year
2017: 1
Where
New Jersey 1
Often inspects with
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Inspection history
1 document, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2017-07-10 | 483 Imprimis NJOF, LLCJul 10, 2017 · Ledgewood, New Jersey | Ledgewood, New Jersey | 12 |
About this profile
What does Louis An inspect?
Louis An appears on 1 document on file covering 1 site, mostly in New Jersey.
What do they cite most often?
21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures), followed by 21 CFR 211.22 and 21 CFR 211.100.
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 Louis An is dated Jul 10, 2017.