Marie A. Fadden
FDA investigator
Appears on 8 documents from 2004 to 2015, mostly at sites in Wisconsin. Most often cites testing and release for distribution (21 CFR 211.165).
- 8
- Documents on file
- 22.8
- Observations per 483
- 2004
- First seen
- 2015
- Most recent
What they cite most
From 110 observations- 21 CFR 211.165Testing and release for distribution13
- 21 CFR 211.110Sampling and testing of in-process materials and drug products8
- 21 CFR 211.160(a)General requirements8
- 21 CFR 211.67(a)Equipment cleaning and maintenance8
- 21 CFR 211.192Production record review7
- 21 CFR 211.113(a)Control of microbiological contamination6
Activity by year
2004: 1, 2009: 3, 2011: 1, 2013: 2, 2015: 1
Where
Wisconsin 5 · Alabama 1 · Indiana 1 · Minnesota 1
Often inspects with
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Inspection history
8 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2015-07-11 | Response Triad GroupJul 11, 2015 · Hartland, Wisconsin | Hartland, Wisconsin | 21 | |
| 2013-03-21 | 483 Nora Apothecary and Alternative Therapies, Inc.Mar 21, 2013 · Indianapolis, Indiana | Indianapolis, Indiana | 6 | |
| 2013-03-07 | 483 Central Admixture Pharmacy Services, Inc. (CAPS)Mar 7, 2013 · Homewood, Alabama | Homewood, Alabama | 12 | |
| 2011-01-07 | 483 H & P Industries, Inc.Jan 7, 2011 · Hartland, Wisconsin | Hartland, Wisconsin | 46 | |
| 2009-07-17 | 483 H & P Industries, Inc. dba Triad GroupJul 17, 2009 · Hartland, Wisconsin | Hartland, Wisconsin | 21 | |
| 2009-07-17 | EIR H & P Industries, Inc. dba Triad GroupJul 17, 2009 · Hartland, Wisconsin | Hartland, Wisconsin | — | |
| 2009-05-08 | 483 Scientific Protein LaboratoriesMay 8, 2009 · Waunakee, Wisconsin | Waunakee, Wisconsin | 29 |
About this profile
What does Marie A. Fadden inspect?
Marie A. Fadden appears on 8 documents on file covering 6 sites, mostly in Wisconsin.
What do they cite most often?
21 CFR 211.165 (testing and release for distribution), followed by 21 CFR 211.110 and 21 CFR 211.160(a).
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 Marie A. Fadden is dated Jul 11, 2015.