FDA Inspection 676576 — Veterans Administration Medical Center
The FDA completed an inspection of Veterans Administration Medical Center on August 23, 2010 in Gainesville, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 23, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Gainesville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 142 | 21 CFR 606.140(a) | Establishment of spec., standards, and test procedures |
| 147 | 21 CFR 606.151(d) | Crossmatching of donor/recipient cells |
| 98 | 21 CFR 606.100(c) | Thorough investigations |