Rose Jean-Mary
FDA investigator
Appears on 15 documents from 2019 to 2025, mostly at sites in New Jersey. Most often cites responsibilities of quality control unit (21 CFR 211.22).
- 15
- Documents on file
- 5.1
- Observations per 483
- 2019
- First seen
- 2025
- Most recent
What they cite most
From 77 observations- 21 CFR 211.22Responsibilities of quality control unit10
- 21 CFR 211.67Equipment cleaning and maintenance9
- 21 CFR 211.68Automatic, mechanical, and electronic equipment8
- 21 CFR 211.160General requirements6
- 21 CFR 211.192Production record review5
- 21 CFR 211.100Written procedures; deviations4
Activity by year
2019: 1, 2020: 1, 2021: 1, 2022: 4, 2023: 1, 2024: 4, 2025: 3
Where
New Jersey 13 · India 1 · South Carolina 1
Often inspects with
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Inspection history
15 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-08-22 | 483 Nephron SC Inc.Aug 22, 2025 · West Columbia, South Carolina | West Columbia, South Carolina | 6 | |
| 2025-08-08 | 483 Hikma Injectables USA IncAug 8, 2025 · Dayton, New Jersey | Dayton, New Jersey | 4 | |
| 2025-04-23 | 483 ENGLEWOOD LAB, INC.Apr 23, 2025 · TOTOWA, New Jersey | TOTOWA, New Jersey | 4 | |
| 2024-11-21 | 483 Vils Pharma Coating, LLCNov 21, 2024 · Edison, New Jersey | Edison, New Jersey | 4 | |
| 2024-10-18 | 483 Salvona Technologies, LLCOct 18, 2024 · Hamilton, New Jersey | Hamilton, New Jersey | 8 | |
| 2024-05-17 | 483 Amneal Complex Products Research LLCMay 17, 2024 · Bridgewater, New Jersey | Bridgewater, New Jersey | 1 | |
| 2024-04-03 | 483 Imprimis NJOF, LLCApr 3, 2024 · Ledgewood, New Jersey | Ledgewood, New Jersey | 5 |
About this profile
What does Rose Jean-Mary inspect?
Rose Jean-Mary appears on 15 documents on file covering 14 sites, mostly in New Jersey.
What do they cite most often?
21 CFR 211.22 (responsibilities of quality control unit), followed by 21 CFR 211.67 and 21 CFR 211.68.
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 Rose Jean-Mary is dated Aug 22, 2025.