FDA Inspection
Gulf Coast Regional Blood CenterGulf Coast Regional Blood Center – FDA Inspection, Nov 3, 2017
Record Details
This FDA Inspection record concerns Gulf Coast Regional Blood Center, with an inspection on November 3, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · e2f396fb-52da-4c96-8e24-7d72b6dab844
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1030603
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.68(b)input/output verification
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.170(a)Adverse Reaction- Reports of Investigations
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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 |
| 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 |
| February 9, 2011 | 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 947455 - 2015-09-04
- FDA Inspection 823909 - 2013-03-19
- FDA Inspection 710462 - 2011-02-09
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