FDA Inspection 841156 — Francine M. Foss
The FDA completed an inspection of Francine M. Foss on Jul 12, 2013 in New Haven, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 12, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- New Haven, CT (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |
| 7393 | 21 CFR 50.25(a)(8) | Participation; refusal and discontinuance |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |
| 7666 | 21 CFR 50.20 | Understandable language |