FDA Inspection
Gulf Coast Regional Blood Center - ConroeGulf Coast Regional Blood Center - Conroe – FDA Inspection, Feb 27, 2018
Record Details
This FDA Inspection record concerns Gulf Coast Regional Blood Center - Conroe, with an inspection on February 27, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 27, 2018
- Product Type
- Biologics
View Company Profile
ID · 164b2b8b-2c57-4a49-80a7-101d5a3555f1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1043144
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 630.10(d)(2)Donation interval
- 21 CFR 606.60(a)Maintain and clean equipment
- 21 CFR 630.10(b)Educational Material
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 640.4(f)Arm preparation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Gulf Coast Regional Blood Center - Conroe
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 1, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 1, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 10, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 9, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 2, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Gulf Coast Regional Blood Center - Conroe
- FDA Inspection 1195232 - 2022-12-01
- FDA Inspection 950993 - 2015-12-01
- FDA Inspection 858250 - 2013-12-10
- FDA Inspection 753880 - 2011-11-09
- FDA Inspection 625452 - 2009-11-02
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.