FDA 483 - Performance Orthopedics Associates Inc - February 22, 2022

An FDA inspection of Performance Orthopedics Associates Inc, a tissue distributor in Birmingham, AL, revealed significant deficiencies in their quality system. The firm failed to establish, maintain, and document appropriate procedures for core Current Good Tissue Practice (CGTP) requirements, including HCT/P receipt and distribution, facility cleaning, and SOP review. Additionally, the quality program lacked procedures for complaint handling and investigation of HCT/P deviations or adverse reactions.