FDA Inspection 647281 — James J. Peters Veterans Affairs Medical Center
The FDA completed an inspection of James J. Peters Veterans Affairs Medical Center on February 25, 2010 in Bronx, 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
- February 25, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Bronx, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 35 | 21 CFR 606.40 | Clean & orderly |