FDA Inspection 945092 — Coqui Blood Salvage, Inc
The FDA completed an inspection of Coqui Blood Salvage, Inc on Oct 5, 2015 in Caguas, PR. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 5, 2015
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Caguas, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12312 | 21 CFR 1271.160(b)(2) | Procedures for complaints and other information |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |