FDA Inspection 736399 — Department Of Defense - Navy (U.S. Naval Hospital Sigonella)
The FDA completed an inspection of Department Of Defense - Navy (U.S. Naval Hospital Sigonella) on Jun 21, 2011 in Sigonella. 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
- Jun 21, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Sigonella (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |