Nathan E. Hellman
FDA investigator
Appears on 6 documents from 2025 to 2026, mostly at sites in California. Most often cites testing and approval or rejection of components, drug product containers, and closures (21 CFR 211.84(a)).
- 6
- Documents on file
- 6.2
- Observations per 483
- 2025
- First seen
- 2026
- Most recent
What they cite most
From 37 observations- 21 CFR 211.84(a)Testing and approval or rejection of components, drug product containers, and closures7
- 21 CFR 211.165(b)Testing and release for distribution4
- 21 CFR 211.192Production record review4
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment3
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products2
- 21 CFR 211.166(a)Stability testing2
Activity by year
2025: 4, 2026: 2
Where
California 5 · Oregon 1
Often inspects with
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Inspection history
6 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-03-27 | 483 Allure Labs, LLCMar 27, 2026 · Hayward, California | Hayward, California | 3 | |
| 2026-02-13 | 483 K.C. Pharmaceuticals, Inc.Feb 13, 2026 · Pomona, California | Pomona, California | 13 | |
| 2025-10-23 | 483 SV Labs CorporationOct 23, 2025 · Watsonville, California | Watsonville, California | 5 | |
| 2025-08-22 | 483 HTO Nevada Inc. dba KirkmanAug 22, 2025 · Lake Oswego, Oregon | Lake Oswego, Oregon | 8 | |
| 2025-04-14 | 483 Columbia Cosmetics Manufacturing, Inc.Apr 14, 2025 · San Leandro, California | San Leandro, California | 6 | |
| 2025-03-14 | 483 Libby Laboratories, IncMar 14, 2025 · Berkeley, California | Berkeley, California | 2 |
About this profile
What does Nathan E. Hellman inspect?
Nathan E. Hellman appears on 6 documents on file covering 6 sites, mostly in California.
What do they cite most often?
21 CFR 211.84(a) (testing and approval or rejection of components, drug product containers, and closures), followed by 21 CFR 211.165(b) and 21 CFR 211.192.
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 Nathan E. Hellman is dated Mar 27, 2026.