FDA Inspection 1179464 — Gulf Coast Regional Blood Center

Gulf Coast Regional Blood Center — FEI 3002133806

The FDA completed an inspection of Gulf Coast Regional Blood Center on Sep 14, 2022 in Houston, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Biologics.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
Sep 14, 2022
Fiscal Year
2022
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Houston, TX (United States)

Citations

IDCFRDescription
1811921 CFR 630.30(b)(2)Unsuitable donation - defer testing