FDA 483 - Sports Tek Medical, Inc. - January 23, 2025

Vital Orthopedics, LLC, an Anaheim-based facility specializing in human cells, tissues, and tissue-based products (HCT/Ps), was inspected by the FDA from January 21 to January 23, 2025. The inspection identified several critical deficiencies in the firm’s handling of biological materials such as bone, skin, and umbilical cord tissues. Key violations centered on inadequate quality control and documentation. Specifically, the FDA noted that incoming tissues were not evaluated for microbial contamination or inspected for physical damage prior to storage and distribution. Furthermore, the firm failed to consistently monitor and document storage temperatures, with no records available for a significant period in late 2024. Additionally, Vital Orthopedics lacked essential maintenance and calibration records for their temperature-monitoring equipment, violating requirements to retain safety-critical documentation for at least ten years. These observations were issued under the authority of the Federal Food, Drug, and Cosmetic Act. While this report does not constitute a final agency determination, the company is required to respond with a corrective action plan or discuss any objections with the FDA. Addressing these issues is essential to ensure the safety and integrity of the biological products handled by the facility.