FDA Inspection 980282 — U.S. Dept. of Veterans Affairs, Northport VA Medical Center
The FDA completed an inspection of U.S. Dept. of Veterans Affairs, Northport VA Medical Center on August 12, 2016 in Northport, NY. 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
- August 12, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Northport, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |