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 were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (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 |