FDA Inspection 661594 — Robley Rex VA Medical Center
The FDA completed an inspection of Robley Rex VA Medical Center on Mar 19, 2010 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 19, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Louisville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 105 | 21 CFR 606.122 | Circular of information - required information |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 54 | 21 CFR 606.40(d)(2) | Provide adequate disposal of blood & blood components |
| 9225 | 21 CFR 606.171 | Biological product deviation report |