Company
United StatesGulf Coast Regional Blood Center, Houston, TX – FDA Inspections
Inspection records and compliance data for Gulf Coast Regional Blood Center in Houston, Texas. 6 FDA inspections on record, 1 Form 483, last inspected February 28, 2025.
Company Profile
This profile covers Gulf Coast Regional Blood Center based in Houston, Texas, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 9, 2011. Last inspected February 28, 2025.
Most cited issue areas
- Thorough investigations2 inspections
- Adverse Reaction- Reports of Investigations1 inspection
- Equipment calibration frequency1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 28, 2025 | Not classified | Biologics | 1264100 |
| September 14, 2022 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1179464 |
| November 3, 2017 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1030603 |
| September 4, 2015 | NAI | Biologics · Blood and Blood Products | 947455 |
| March 19, 2013 | VAI | Biologics · Blood and Blood Products | 823909 |
| February 9, 2011 | VAI | Biologics · Blood and Blood Products | 710462 |
FDA documents
Form 483s (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Gulf Coast Regional Blood Center
FEI Number
3002133806
Address
1400 La Concha Ln, Houston, Texas 77054, United States
Country
United States
ID: 7bef4346-91b9-4489-9ca6-b45fb4424760