Andrew Le
FDA investigator
Appears on 10 documents from 2022 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).
- 10
- Documents on file
- 6.8
- Observations per 483
- 2022
- First seen
- 2025
- Most recent
What they cite most
From 68 observations- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures15
- 21 CFR 211.67Equipment cleaning and maintenance6
- 21 CFR 211.165Testing and release for distribution5
- 21 CFR 211.192Production record review5
- 21 CFR 211.100(a)Written procedures; deviations4
- 21 CFR 211.160(a)General requirements4
Activity by year
2022: 1, 2023: 3, 2024: 4, 2025: 2
Where
California 5 · India 2 · Macau 1 · Utah 1 · Washington 1
Often inspects with
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Inspection history
10 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-12-17 | 483 Macau-Union Pharmaceutical LimitedDec 17, 2025 · Macau, Macau | Macau, Macau | 8 | |
| 2025-01-17 | 483 Private Label Partners, Inc.Jan 17, 2025 · Santa Ana, California | Santa Ana, California | 7 | |
| 2024-07-26 | 483 Bhargava Phytolab Private LimitedJul 26, 2024 · Bhiwadi, India | Bhiwadi, India | 9 | |
| 2024-06-14 | 483 Silgan Unicep Packaging LieJun 14, 2024 · Spokane, Washington | Spokane, Washington | 5 | |
| 2024-05-10 | 483 Polypeptide Laboratories IncMay 10, 2024 · Torrance, California | Torrance, California | 1 | |
| 2024-04-05 | 483 Dr. Brite LLCApr 5, 2024 · Fullerton, California | Fullerton, California | 6 | |
| 2023-11-17 | 483 Wedgewood Connect, LLCNov 17, 2023 · San Jose, California | San Jose, California | 8 |
About this profile
What does Andrew Le inspect?
Andrew Le appears on 10 documents on file covering 10 sites, mostly in California.
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 211.67 and 21 CFR 211.165.
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 Andrew Le is dated Dec 17, 2025.