FDA Inspection 1090197 — U.S. Navy Medicine Readiness And Training Command Rota Spain
The FDA completed an inspection of U.S. Navy Medicine Readiness And Training Command Rota Spain on May 14, 2019 in Rota. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 14, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Rota (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 78 | 21 CFR 606.100(c) | Record review prior to release |