FDA Inspection 925908 — VA New York Harbor Healthcare System
The FDA completed an inspection of VA New York Harbor Healthcare System on May 12, 2015 in Brooklyn, NY. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 12, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Brooklyn, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 95 | 21 CFR 606.100(b)(16) | Labeling procedures to avoid labeling mix-ups |