FDA Inspection
Gulf Coast Regional Blood CenterGulf Coast Regional Blood Center – FDA Inspection, Feb 9, 2011
Record Details
This FDA Inspection record concerns Gulf Coast Regional Blood Center, with an inspection on February 9, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 9, 2011
- Product Type
- Biologics
View Company Profile
ID · e3b86b30-7a1e-4bdc-880e-08f59e1f8bb6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 710462
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Gulf Coast Regional Blood Center
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2025 | Not classified | Dallas District Office | |
| September 14, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 3, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 4, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 19, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Gulf Coast Regional Blood Center
- FDA Inspection 1264100 - 2025-02-28
- FDA Inspection 1179464 - 2022-09-14
- FDA Inspection 1030603 - 2017-11-03
- FDA Inspection 947455 - 2015-09-04
- FDA Inspection 823909 - 2013-03-19
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.