Rebecca E. Dombrowski
FDA investigator
Appears on 14 documents from 2006 to 2019, mostly at sites in Michigan. Most often cites production record review (21 CFR 211.192).
- 14
- Documents on file
- 7.5
- Observations per 483
- 2006
- First seen
- 2019
- Most recent
What they cite most
From 90 observations- 21 CFR 211.192Production record review11
- 21 CFR 211.67Equipment cleaning and maintenance8
- 21 CFR 211.100Written procedures; deviations7
- 21 CFR 211.22Responsibilities of quality control unit7
- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.160General requirements4
Activity by year
2006: 2, 2008: 2, 2012: 1, 2013: 3, 2015: 3, 2018: 2, 2019: 1
Where
Michigan 11 · India 2 · West Virginia 1
Often inspects with
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Inspection history
14 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-06-11 | 483 Sun Pharmaceutical Industries Ltd.Jun 11, 2019 · Halol, India | Halol, India | 4 | |
| 2018-09-28 | 483 Cipla Limited Verna Industrial EstateSep 28, 2018 · Verna, India | Verna, India | 2 | |
| 2018-04-12 | 483 Mylan Pharmaceuticals Inc.Apr 12, 2018 · Morgantown, West Virginia | Morgantown, West Virginia | 13 | |
| 2015-07-23 | 483 Pfizer, Inc.Jul 23, 2015 · Rochester, Michigan | Rochester, Michigan | 2 | |
| 2015-07-23 | 483 JHP Pharmaceuticals, Inc.Jul 23, 2015 · Rochester, Michigan | Rochester, Michigan | 3 | |
| 2015-07-09 | 483 Pharmacia & Upjohn Company LLCJul 9, 2015 · Kalamazoo, Michigan | Kalamazoo, Michigan | 8 | |
| 2013-03-06 | 483 Portage Pharmacy, Inc.Mar 6, 2013 · Portage, Michigan | Portage, Michigan | 14 |
About this profile
What does Rebecca E. Dombrowski inspect?
Rebecca E. Dombrowski appears on 14 documents on file covering 10 sites, mostly in Michigan.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.67 and 21 CFR 211.100.
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 Rebecca E. Dombrowski is dated Jun 11, 2019.