FDA Inspection 954375 — Veterans Affairs Medical Center
The FDA completed an inspection of Veterans Affairs Medical Center on Dec 17, 2015 in Saint Louis, 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
- Dec 17, 2015
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 143 | 21 CFR 606.140(b) | Provisions to monitor lab test procedures & instruments |
| 238 | 21 CFR 640.11(a) | General requirements - storage |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 98 | 21 CFR 606.100(c) | Thorough investigations |