Damaris Y. Hernandez
FDA investigator · also recorded as Ors Lee Damaris Hernandez
Appears on 17 documents from 2022 to 2026, mostly at sites in Florida. Most often cites responsibilities of quality control unit (21 CFR 211.22).
- 17
- Documents on file
- 5.1
- Observations per 483
- 2022
- First seen
- 2026
- Most recent
What they cite most
From 83 observations- 21 CFR 211.22Responsibilities of quality control unit13
- 21 CFR 211.113Control of microbiological contamination8
- 21 CFR 211.192Production record review7
- 21 CFR 211.67Equipment cleaning and maintenance7
- 21 CFR 211.160General requirements6
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures6
Activity by year
2022: 5, 2023: 3, 2024: 2, 2025: 5, 2026: 2
Where
Florida 9 · Texas 2 · Brazil 1 · India 1 · Kansas 1 · New Jersey 1
Often inspects with
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Inspection history
17 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-03-20 | 483 Bausch and Lomb IncorporatedMar 20, 2026 · Tampa, Florida | Tampa, Florida | 3 | |
| 2026-01-30 | 483 Catalent Pharma Solutions, LLCJan 30, 2026 · Saint Petersburg, Florida | Saint Petersburg, Florida | 2 | |
| 2025-09-18 | 483 Immacule Lifesciences Private LimitedSep 18, 2025 · Solan, India | Solan, India | 8 | |
| 2025-06-17 | 483 Glenmark Pharmaceuticals Inc.Jun 17, 2025 · Monroe, North Carolina | Monroe, North Carolina | 5 | |
| 2025-05-05 | 483 Geri-Care Pharmaceuticals, CorpMay 5, 2025 · Lakewood, New Jersey | Lakewood, New Jersey | 5 | |
| 2025-03-20 | 483 Pharmco Laboratories Inc.Mar 20, 2025 · Titusville, Florida | Titusville, Florida | 6 | |
| 2025-03-20 | Amended 483 Pharmco Laboratories Inc.Mar 20, 2025 · Titusville, Florida | Titusville, Florida | 6 |
About this profile
What does Damaris Y. Hernandez inspect?
Damaris Y. Hernandez appears on 17 documents on file covering 16 sites, mostly in Florida.
What do they cite most often?
21 CFR 211.22 (responsibilities of quality control unit), followed by 21 CFR 211.113 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 Damaris Y. Hernandez is dated Mar 20, 2026.