FDA Inspection
GREFIGREFI – FDA Inspection, Oct 1, 2019
Record Details
This FDA Inspection record concerns GREFI, with an inspection on October 1, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- GREFI
- Inspection Date
- October 1, 2019
- Product Type
- Biologics
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ID · f0bd9547-c9d4-4513-bd6e-1d85bd384b25
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1101917
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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Other FDA inspections of GREFI
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2021 | OAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| April 5, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 31, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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