Gulf Coast Regional Blood CenterSeptember 14, 2022

FDA 483 - Gulf Coast Regional Blood Center - September 14, 2022

Record Details

An FDA inspection of Gulf Coast Regional Blood Center in Houston, TX, revealed a significant issue regarding donor eligibility. The firm failed to properly defer a donor of blood and blood components, despite their own reference table indicating an indefinite deferral. This indicates a lapse in adherence to established donor screening protocols.

Company: Gulf Coast Regional Blood Center
Inspection Date: September 14, 2022
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West III
People: Sunitha K. Rajaram (issuing_officer)
Bobbi Miller
Maira P. Brading (investigator)

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