FDA Inspection 577640 — 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 April 29, 2009 in Northport, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 29, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Northport, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 3684 | 21 CFR 820.75(a) | Documentation - specific items |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |