Karen A. Briggs
FDA investigator
Appears on 19 documents from 2021 to 2026, most often at sites in Virginia. Most often cites design and construction features (21 CFR 211.42).
- 19
- Documents on file
- 5.3
- Observations per 483
- 2021
- First seen
- 2026
- Most recent
What they cite most
From 106 observations- 21 CFR 211.42Design and construction features14
- 21 CFR 211.67Equipment cleaning and maintenance13
- 21 CFR 211.113Control of microbiological contamination12
- 21 CFR 211.192Production record review8
- FDCA 501(a)(2)(A)Insanitary conditions8
- 21 CFR 211.22Responsibilities of quality control unit7
Activity by year
2021: 2, 2022: 2, 2023: 5, 2024: 2, 2025: 5, 2026: 3
Where
Virginia 4 · France 3 · New Jersey 3 · Pennsylvania 3 · India 2 · China 1
Often inspects with
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Inspection history
19 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-04-24 | 483 Jiangsu Hansoh Pharmaceutical Group Co. Ltd. No 5. Dongjin Road, Economic and Technical Development ZoneApr 24, 2026 · Lianyungang, China | Lianyungang, China | 1 | |
| 2026-01-22 | Warning letter Excel VisionJan 22, 2026 · Annonay, France | Annonay, France | — | |
| 2026-01-22 | 483 Excel VisionJan 22, 2026 · Annonay, France | Annonay, France | 11 | |
| 2025-09-26 | 483 Baxter Onocology GmbHSep 26, 2025 · Halle (Westf.), Germany | Halle (Westf.), Germany | 12 | |
| 2025-09-16 | 483 Fareva AmboiseSep 16, 2025 · Poce Sur Cisse, France | Poce Sur Cisse, France | 9 | |
| 2025-06-20 | 483 Granules India LimitedJun 20, 2025 · Sangareddy, India | Sangareddy, India | 1 | |
| 2025-05-23 | 483 Fareva Richmond, Inc.May 23, 2025 · Henrico, Virginia | Henrico, Virginia | 1 |
About this profile
What does Karen A. Briggs inspect?
Karen A. Briggs appears on 19 documents on file covering 16 sites, most often in Virginia.
What do they cite most often?
21 CFR 211.42 (design and construction features), followed by 21 CFR 211.67 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 Karen A. Briggs is dated Apr 24, 2026.