FDA 483 - RESET TECHNOLOGY CORPORATION - December 20, 2024

RESET TECHNOLOGY CORPORATION, a manufacturer of ResetSmile devices in Englewood Cliffs, NJ, was cited with 12 observations during an FDA inspection from October to December 2024. The inspection revealed significant deficiencies across its quality system, including a lack of documented procedures for process validation, design controls, nonconforming product, rework, environmental controls, complaint handling, CAPA, training, and software validation. Additionally, the firm failed to label devices with Unique Device Identifiers (UDI) and submit required information to the GUDID.