FDA Inspection 653953 — University Of South Florida Morsani College Of Medicine
The FDA completed an inspection of University Of South Florida Morsani College Of Medicine on Mar 30, 2010 in Tampa, FL. 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, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |