FDA EIR - South Texas Blood and Tissue Center - January 18, 2019

An FDA inspection of the South Texas Blood and Tissue Center, located in San Antonio, TX, was conducted from January 17 to January 18, 2019. This routine and comprehensive evaluation adhered to Compliance Program 7342.001, which governs the inspection of licensed and unlicensed blood banks. The scope included a thorough review of the Donor Eligibility, Quality Assurance, and Product Collection systems, encompassing standard operating procedures, personnel training, facilities, equipment, records, and computer systems. The center is registered to collect whole blood, apheresis red blood cells, platelets, and plasma from allogenic donors, with products transported to its headquarters for testing, processing, and distribution. Notably, the inspection concluded without any objectionable findings, and no FDA Form 483 was issued, indicating compliance with regulatory standards. While four Biologic Product Deviation Reports were noted from 2017-2018, primarily for undeclared travel and one needle stick injury which led to a recall, these were appropriately managed by the firm. No specific violations or required corrective actions were identified during this assessment.