FDA 483 - Performance Orthopedics Associates Inc - June 13, 2025

Performance Orthopedics Associates Inc, a human tissue distributor in Mountain Brk, AL, was cited for significant deficiencies during an FDA inspection. Observations included a widespread lack of established procedures for core Current Good Tissue Practice (CGTP) requirements, including HCT/P manufacturing, receipt, distribution, facility sanitation, and quality program elements like complaint handling and deviation investigations. Additionally, the firm failed to retain HCT/P records for the required 10-year period.