Karen L. Kosar
FDA investigator
Appears on 4 documents from 2013 to 2019, mostly at sites in New York. Most often cites control of microbiological contamination (21 CFR 211.113).
- 4
- Documents on file
- 7.8
- Observations per 483
- 2013
- First seen
- 2019
- Most recent
What they cite most
From 31 observations- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.166Stability testing4
- 21 CFR 211.42Design and construction features4
- 21 CFR 314.80(b)Postmarketing reporting of adverse drug experiences4
- 21 CFR 211.28Personnel responsibilities3
- 21 CFR 211.160(b)General requirements2
Activity by year
2013: 2, 2016: 1, 2019: 1
Where
New York 4
Often inspects with
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Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-04-11 | 483 Jerome Stevens Pharmaceuticals, Inc.Apr 11, 2019 · Bohemia, New York | Bohemia, New York | 4 | |
| 2016-04-18 | 483 Pine Pharmacy and Home Care Products Center Inc.Apr 18, 2016 · Williamsvil le, New York | Williamsvil le, New York | 8 | |
| 2013-12-16 | 483 Pine Pharmacy and Home Care Products Center, IncDec 16, 2013 · Williamsvil le, New York | Williamsvil le, New York | 9 | |
| 2013-07-19 | 483 Pine Pharmacy and Home Care Products Center, Inc.Jul 19, 2013 · Williamsvil le, New York | Williamsvil le, New York | 10 |
About this profile
What does Karen L. Kosar inspect?
Karen L. Kosar appears on 4 documents on file covering 2 sites, mostly in New York.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.166 and 21 CFR 211.42.
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 Karen L. Kosar is dated Apr 11, 2019.