FDA 483 - Elite Orthopedics, LLC - July 15, 2025

An FDA inspection of Elite Orthopedics, LLC in Columbia, MO, an HCTP establishment, revealed significant deficiencies in their quality system. The firm was cited for failing to maintain current procedures, adequately document equipment maintenance and HCT/P storage temperatures, and follow proper record-keeping practices for tissue products. These issues indicate a lack of control over critical aspects of HCT/P handling and distribution.