Edmund F. Mrak Jr
FDA investigator
Appears on 7 documents from 2012 to 2022, most often at sites in Massachusetts. Most often cites general requirements (21 CFR 211.160).
- 7
- Documents on file
- 4.8
- Observations per 483
- 2012
- First seen
- 2022
- Most recent
What they cite most
From 33 observations- 21 CFR 211.160General requirements7
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.192Production record review3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.194Laboratory records2
Activity by year
2012: 1, 2014: 1, 2016: 3, 2022: 2
Where
Massachusetts 3 · India 1 · New Jersey 1 · Rhode Island 1 · Switzerland 1
Often inspects with
Camerson E. Moore· Jonathan G. Matrisciano· Kathleen M. Jordan
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Inspection history
7 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2022-12-16 | 483 CARBOGEN AMCIS AGDec 16, 2022 · Bubendorf, Switzerland | Bubendorf, Switzerland | 2 | |
| 2022-08-25 | 483 Form 483 · FEI 3002889358Aug 25, 2022 · Branchburg, New Jersey | Branchburg, New Jersey | 2 | |
| 2016-08-03 | 483 Alexion Pharmaceuticals, IncAug 3, 2016 · Smithfield, Rhode Island | Smithfield, Rhode Island | 3 | |
| 2016-05-13 | 483 Kumar Organic Products LimitedMay 13, 2016 · Bangalore, India | Bangalore, India | — | |
| 2016-02-05 | 483 Ocular Therapculix, IncFeb 5, 2016 · Bedford, Massachusetts | Bedford, Massachusetts | 10 | |
| 2014-02-20 | 483 Central Admixture Pharmacy Services, Inc.Feb 20, 2014 · Woburn, Massachusetts | Woburn, Massachusetts | 10 | |
| 2012-03-21 | 483 Exemplar Pharmaceuticals LLCMar 21, 2012 · Fall River, Massachusetts | Fall River, Massachusetts | 2 |
About this profile
What does Edmund F. Mrak Jr inspect?
Edmund F. Mrak Jr appears on 7 documents on file covering 7 sites, most often in Massachusetts.
What do they cite most often?
21 CFR 211.160 (general requirements), followed by 21 CFR 211.42 and 21 CFR 211.113.
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 Jr is dated Dec 16, 2022.