FDA Inspection 1005717 — Veterans Administration Medical Center Pathology & Lab Medicine Svc (113)
The FDA completed an inspection of Veterans Administration Medical Center Pathology & Lab Medicine Svc (113) on February 6, 2017 in Pineville, LA. 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 6, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Pineville, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |