FDA Inspection 826483 — Department Of Veterans Affairs Medical Center
The FDA completed an inspection of Department Of Veterans Affairs Medical Center on Apr 2, 2013 in Kansas City, MO. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 2, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Kansas City, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 198 | 21 CFR 640.2(c)(3) | Blood not stored between 1-6 deg / shipped 1-10 deg |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 91 | 21 CFR 606.100(b)(12) | Criteria for suitability of reissue of returned blood |