FDA Inspection 1262290 — Ioannis Lougaris VA Medical Center Laboratory Service (113) Blood Bank
The FDA completed an inspection of Ioannis Lougaris VA Medical Center Laboratory Service (113) Blood Bank on Feb 28, 2025 in Reno, NV. 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
- Feb 28, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Reno, NV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 155 | 21 CFR 606.160(b) | Required records |
| 18038 | 21 CFR 606.100(b) | SOPs for investigations, records |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 98 | 21 CFR 606.100(c) | Thorough investigations |