Edmund F. Mrak
FDA investigator
Appears on 30 documents from 2010 to 2026, most often at sites in New York. Most often cites design and construction features (21 CFR 211.42).
- 30
- Documents on file
- 5.7
- Observations per 483
- 2010
- First seen
- 2026
- Most recent
What they cite most
From 170 observations- 21 CFR 211.42Design and construction features35
- 21 CFR 211.113Control of microbiological contamination21
- 21 CFR 211.67Equipment cleaning and maintenance13
- 21 CFR 211.192Production record review10
- 21 CFR 211.63Equipment design, size, and location9
- 21 CFR 211.68Automatic, mechanical, and electronic equipment9
Activity by year
2010: 1, 2014: 1, 2015: 1, 2016: 1, 2017: 1, 2018: 3, 2019: 2, 2020: 3, 2021: 1, 2022: 6, 2023: 5, 2024: 4, 2026: 1
Where
New York 7 · Vermont 5 · Maine 3 · Maryland 3 · New Jersey 3 · Connecticut 2
Often inspects with
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Inspection history
30 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-05-08 | 483 Perrigo New York, Inc.May 8, 2026 · Bronx, New York | Bronx, New York | 3 | |
| 2024-06-25 | 483 Hikma Injectables USA Inc.Jun 25, 2024 · Dayton, New Jersey | Dayton, New Jersey | 4 | |
| 2024-04-24 | 483 American Regent, Inc.Apr 24, 2024 · Shirley, New York | Shirley, New York | 7 | |
| 2024-04-03 | 483 Bell-More Labs, IncApr 3, 2024 · Hampstead, Maryland | Hampstead, Maryland | 11 | |
| 2024-01-17 | 483 Juno Pharma Canada Inc.Jan 17, 2024 · Montreal, Canada | Montreal, Canada | 2 | |
| 2023-12-05 | 483 University Instrumentation Center at UNHDec 5, 2023 · Durham, New Hampshire | Durham, New Hampshire | 4 | |
| 2023-09-21 | 483 SEAWAY PHARMASep 21, 2023 · Massena, New York | Massena, New York | 8 |
About this profile
What does Edmund F. Mrak inspect?
Edmund F. Mrak appears on 30 documents on file covering 26 sites, most often in New York.
What do they cite most often?
21 CFR 211.42 (design and construction features), followed by 21 CFR 211.113 and 21 CFR 211.67.
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 Edmund F. Mrak is dated May 8, 2026.