Marian E. Ramirez
FDA investigator
Appears on 20 documents from 2016 to 2025, mostly at sites in Puerto Rico. Most often cites production record review (21 CFR 211.192).
- 20
- Documents on file
- 4.0
- Observations per 483
- 2016
- First seen
- 2025
- Most recent
What they cite most
From 80 observations- 21 CFR 211.192Production record review13
- 21 CFR 211.22Responsibilities of quality control unit10
- 21 CFR 211.160General requirements7
- 21 CFR 211.100Written procedures; deviations6
- 21 CFR 211.165Testing and release for distribution6
- 21 CFR 211.166(a)Stability testing6
Activity by year
2016: 1, 2018: 2, 2019: 2, 2020: 1, 2021: 2, 2022: 4, 2023: 4, 2024: 3, 2025: 1
Where
Puerto Rico 15 · Florida 2 · Brazil 1 · Canada 1 · Delaware 1
Often inspects with
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Inspection history
20 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-01-31 | 483 Diversified Chemical ProductsJan 31, 2025 · Wilmington, Delaware | Wilmington, Delaware | 2 | |
| 2024-11-25 | 483 American Injectables Inc.Nov 25, 2024 · Brooksville, Florida | Brooksville, Florida | 1 | |
| 2024-03-15 | 483 Max Chemical, Inc.Mar 15, 2024 · Rio Piedras, Puerto Rico | Rio Piedras, Puerto Rico | 6 | |
| 2024-01-18 | 483 Little Moon Essentials LLCJan 18, 2024 · Dania Beach, Florida | Dania Beach, Florida | 5 | |
| 2023-10-23 | 483 Omega & Delta Co. Inc.Oct 23, 2023 · Carolina, Puerto Rico | Carolina, Puerto Rico | 3 | |
| 2023-09-20 | 483 McNeil Healthcare, LLCSep 20, 2023 · Las Piedras, Puerto Rico | Las Piedras, Puerto Rico | 5 | |
| 2023-08-09 | 483 União QuÍmica Farmacêutica Nacional SAAug 9, 2023 · GUARULHOS, Brazil | GUARULHOS, Brazil | 2 |
About this profile
What does Marian E. Ramirez inspect?
Marian E. Ramirez appears on 20 documents on file covering 17 sites, mostly in Puerto Rico.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.22 and 21 CFR 211.160.
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 Marian E. Ramirez is dated Jan 31, 2025.