FDA Inspection 998342 — Robley Rex VA Medical Center
The FDA completed an inspection of Robley Rex VA Medical Center on Jan 13, 2017 in Louisville, KY. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 13, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Louisville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 63 | 21 CFR 606.65 | Safe, sanitary, orderly storage |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |