Anita R. Michael
FDA investigator
Appears on 18 documents from 2006 to 2020, mostly at sites in Pennsylvania. Most often cites production record review (21 CFR 211.192).
- 18
- Documents on file
- 6.0
- Observations per 483
- 2006
- First seen
- 2020
- Most recent
What they cite most
From 103 observations- 21 CFR 211.192Production record review17
- 21 CFR 211.42(a)Design and construction features13
- 21 CFR 211.113Control of microbiological contamination7
- 21 CFR 211.160General requirements7
- 21 CFR 211.110Sampling and testing of in-process materials and drug products6
- 21 CFR 211.165Testing and release for distribution5
Activity by year
2006: 1, 2008: 1, 2010: 3, 2013: 2, 2014: 1, 2015: 4, 2016: 1, 2017: 2, 2018: 2, 2020: 1
Where
Pennsylvania 17 · Delaware 1
Often inspects with
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Inspection history
18 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2020-02-09 | 483 McNeil Consumer Healthcare, Div OfFeb 9, 2020 · Fort Washington, Pennsylvania | Fort Washington, Pennsylvania | 7 | |
| 2018-04-24 | 483 PPL Healthcare LLCApr 24, 2018 · SELLERSVILLE, Pennsylvania | SELLERSVILLE, Pennsylvania | 1 | |
| 2018-03-05 | 483 Janssen Biotech, Inc.Mar 5, 2018 · Malvern, Pennsylvania | Malvern, Pennsylvania | 1 | |
| 2017-07-07 | 483 Kenvue Brands LLCJul 7, 2017 · Lititz, Pennsylvania | Lititz, Pennsylvania | 1 | |
| 2017-06-22 | 483 SaveWay Compounding Pharmacy, Inc.Jun 22, 2017 · Newark, Delaware | Newark, Delaware | 1 | |
| 2016-04-20 | 483 Catalent Micron Technologies, IncApr 20, 2016 · Malvern, Pennsylvania | Malvern, Pennsylvania | 1 | |
| 2015-11-20 | 483 Central Admixture Pharmacy Services Inc.Nov 20, 2015 · Horsham, Pennsylvania | Horsham, Pennsylvania | 9 |
About this profile
What does Anita R. Michael inspect?
Anita R. Michael appears on 18 documents on file covering 12 sites, mostly in Pennsylvania.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.42(a) 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 Anita R. Michael is dated Feb 9, 2020.