Patricia F. Hughes
FDA investigator
Appears on 2 documents from 2022 to 2023, mostly at sites in California. Most often cites written procedures; deviations (21 CFR 211.100).
- 2
- Documents on file
- 3.0
- Observations per 483
- 2022
- First seen
- 2023
- Most recent
What they cite most
From 6 observations- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 600.14Reporting of biological product deviations by licensed manufacturers1
Activity by year
2022: 1, 2023: 1
Where
California 1 · North Carolina 1
Often inspects with
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Inspection history
2 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-02-10 | 483 FUJIFILM Diosynth Biotechnologies U.S.A., IncFeb 10, 2023 · North Carolina | North Carolina | 3 | |
| 2022-07-15 | 483 Revance Therapeutics, Inc.Jul 15, 2022 · Newark, California | Newark, California | 3 |
About this profile
What does Patricia F. Hughes inspect?
Patricia F. Hughes appears on 2 documents on file covering 2 sites, mostly in California.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 211.113 and 21 CFR 211.160.
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 Patricia F. Hughes is dated Feb 10, 2023.