FDA 483 - Tuxedo Imaging - September 19, 2025

Tuxedo Imaging, a manufacturer of Class II dental devices in Akron, OH, was inspected and received a Form FDA 483 with 14 observations. The inspection revealed significant deficiencies across its quality system, particularly concerning the lack of established procedures for design controls, purchasing, complaint handling, and document control. The firm also failed to maintain required records such as design history files and device master records.