FDA 483 - TMJ Services LLC - December 12, 2023

TMJ Services LLC, a manufacturer of the Urbanek Device in Brentwood, IN, was inspected by the FDA and received 12 observations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for CAPA, complaint handling, nonconforming product control, rework, device master records, software validation, design controls, process controls, document approval, supplier management, and personnel training. These issues indicate a widespread lack of established and implemented quality system procedures.