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

Elite Orthopedics, LLC in Columbia, MO, an HCTP establishment, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant deficiencies in the firm's record-keeping practices, including the use of outdated procedures, failure to maintain equipment documentation and temperature logs, and not following core Current Good Tissue Practices for HCT/Ps. These issues indicate a systemic problem with maintaining proper documentation and adherence to established procedures for human tissue products.