FDA Inspection
GREFIGREFI – FDA Inspection, Aug 31, 2015
Record Details
This FDA Inspection record concerns GREFI, with an inspection on August 31, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- GREFI
- Inspection Date
- August 31, 2015
- Product Type
- Biologics
View Company Profile
ID · 9a532bda-b659-4cec-a304-f075518e0336
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 941188
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Procedures for all other requirements
Full citation text and observation details available on the Dashboard.
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 |
| October 1, 2019 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 5, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for GREFI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.