FDA Inspection
Coqui Blood Salvage, IncCoqui Blood Salvage, Inc – FDA Inspection, Oct 5, 2015
Record Details
This FDA Inspection record concerns Coqui Blood Salvage, Inc, with an inspection on October 5, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Coqui Blood Salvage, Inc
- Inspection Date
- October 5, 2015
- Product Type
- Biologics
View Company Profile
ID · 93b946b5-2d59-4552-9550-874d8e058d57
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 945092
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
- 21 CFR 1271.160(b)(2)Procedures for complaints and other information
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Coqui Blood Salvage, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 5, 2021 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 4, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Coqui Blood Salvage, Inc
- FDA Inspection 1156494 - 2021-11-05
- FDA Inspection 1054414 - 2018-05-04
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