Sandra A. Hughes
FDA investigator
Appears on 23 documents from 2009 to 2019, most often at sites in Wisconsin. Most often cites equipment cleaning and maintenance (21 CFR 211.67).
- 23
- Documents on file
- 10.2
- Observations per 483
- 2009
- First seen
- 2019
- Most recent
What they cite most
From 206 observations- 21 CFR 211.67Equipment cleaning and maintenance23
- 21 CFR 211.160General requirements18
- 21 CFR 211.113Control of microbiological contamination15
- 21 CFR 211.192Production record review15
- 21 CFR 211.110Sampling and testing of in-process materials and drug products10
- 21 CFR 211.165(a)Testing and release for distribution9
Activity by year
2009: 2, 2010: 2, 2011: 2, 2012: 2, 2013: 2, 2015: 2, 2016: 3, 2017: 3, 2018: 4, 2019: 1
Where
Wisconsin 10 · India 4 · China 2 · Illinois 2 · Italy 2 · Missouri 2
Often inspects with
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Inspection history
23 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-03-15 | 483 Glenmark Pharmaceuticals LimitedMar 15, 2019 · Colvale-Bardez, India | Colvale-Bardez, India | — | |
| 2018-08-31 | 483 Morton Drug Company dba Morton LTCAug 31, 2018 · Neenah, Wisconsin | Neenah, Wisconsin | 3 | |
| 2018-06-29 | 483 Pfizer Italia S.r.l.Jun 29, 2018 · Ascoli Piceno, Italy | Ascoli Piceno, Italy | 4 | |
| 2018-05-16 | 483 Akorn, IncMay 16, 2018 · Decatur, Illinois | Decatur, Illinois | 13 | |
| 2018-05-03 | 483 Akorn, Inc.May 3, 2018 · Decatur, Illinois | Decatur, Illinois | 13 | |
| 2017-11-30 | 483 Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. ParkNov 30, 2017 · Polepally, India | Polepally, India | 3 | |
| 2017-06-03 | 483 Biocon Biologics LimitedJun 3, 2017 · Bangalore, India | Bangalore, India | 2 |
About this profile
What does Sandra A. Hughes inspect?
Sandra A. Hughes appears on 23 documents on file covering 17 sites, most often in Wisconsin.
What do they cite most often?
21 CFR 211.67 (equipment cleaning and maintenance), followed by 21 CFR 211.160 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 Sandra A. Hughes is dated Mar 15, 2019.