FDA Inspection 1016453 — 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 17, 2017 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 17, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Rota (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 113 | 21 CFR 606.121(b) | Collection/initial processing facility labels |
| 137 | 21 CFR 606.121(c)(13) | Unapproved encoded/machine readable information |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |