FDA Inspection 575730 — Franklin, E. Ruffin
The FDA completed an inspection of Franklin, E. Ruffin on Mar 30, 2009 in Raleigh, NC. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 30, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Raleigh, NC (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |