Carrie A. Hughes
FDA investigator
Appears on 8 documents from 2017 to 2023, most often at sites in California. Most often cites design controls (21 CFR 820.30).
- 8
- Documents on file
- 8.5
- Observations per 483
- 2017
- First seen
- 2023
- Most recent
What they cite most
From 68 observations- 21 CFR 820.30Design controls10
- 21 CFR 211.100Written procedures; deviations9
- 21 CFR 211.22Responsibilities of quality control unit9
- 21 CFR 211.192Production record review7
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.68Automatic, mechanical, and electronic equipment5
Activity by year
2017: 2, 2018: 3, 2019: 1, 2020: 1, 2023: 1
Where
California 3 · India 3 · Arizona 2
Often inspects with
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Inspection history
8 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-10-06 | 483 Abraxis BioScience, LLCOct 6, 2023 · Phoenix, Arizona | Phoenix, Arizona | 6 | |
| 2020-02-19 | 483 Abraxis BioScience, LLCFeb 19, 2020 · Phoenix, Arizona | Phoenix, Arizona | 4 | |
| 2019-11-08 | 483 Calyx Chemicals & Pharmaceuticals LimitedNov 8, 2019 · Boisar, India | Boisar, India | 4 | |
| 2018-06-29 | 483 B. Braun US Pharmaceutical Manufacturing LLCJun 29, 2018 · Irvine, California | Irvine, California | 8 | |
| 2018-03-15 | 483 Amneal Oncology Private LimitedMar 15, 2018 · Mahaboobnagar, India | Mahaboobnagar, India | 4 | |
| 2018-03-06 | 483 Auronext Pharma A-1128, Riico Industrial Area, Phase -Mar 6, 2018 · Bhiwadi, India | Bhiwadi, India | 2 | |
| 2017-03-31 | 483 Amphastar Pharmaceuticals, IncMar 31, 2017 · Rancho Cucamonga, California | Rancho Cucamonga, California | 20 |
About this profile
What does Carrie A. Hughes inspect?
Carrie A. Hughes appears on 8 documents on file covering 6 sites, most often in California.
What do they cite most often?
21 CFR 820.30 (design controls), followed by 21 CFR 211.100 and 21 CFR 211.22.
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 Carrie A. Hughes is dated Oct 6, 2023.