FDA Inspection 649922 — 21St Century Oncology, LLC
The FDA completed an inspection of 21St Century Oncology, LLC on Jan 29, 2010 in Port Charlotte, 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
- Jan 29, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Port Charlotte, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 89 | 21 CFR 606.100(b)(10) | Controlling storage temperatures |