FDA Inspection 1015126 — 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 May 10, 2017 in Sigonella. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 10, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Sigonella (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 113 | 21 CFR 606.121(b) | Collection/initial processing facility labels |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |