Lena Nguyen
FDA investigator
Appears on 3 documents from 2024 to 2025, mostly at sites in California. Most often cites testing and approval or rejection of components, drug product containers, and closures (21 CFR 211.84(d)(1)).
- 3
- Documents on file
- 3.3
- Observations per 483
- 2024
- First seen
- 2025
- Most recent
What they cite most
From 10 observations- 21 CFR 211.84(d)(1)Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.122(d)Materials examination and usage criteria1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(a)Stability testing1
Activity by year
2024: 1, 2025: 2
Where
California 3
Often inspects with
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-03-07 | 483 PureTek CorporationMar 7, 2025 · San Fernando, California | San Fernando, California | 2 | |
| 2025-01-17 | 483 Private Label Partners, Inc.Jan 17, 2025 · Santa Ana, California | Santa Ana, California | 7 | |
| 2024-10-30 | Amended 483 Morgan Gallacher, Inc DBA CustomOct 30, 2024 · Santa Fe Springs, California | Santa Fe Springs, California | 1 |
About this profile
What does Lena Nguyen inspect?
Lena Nguyen appears on 3 documents on file covering 3 sites, mostly in California.
What do they cite most often?
21 CFR 211.84(d)(1) (testing and approval or rejection of components, drug product containers, and closures), followed by 21 CFR 211.100(a) and 21 CFR 211.122(d).
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 Lena Nguyen is dated Mar 7, 2025.