FDA 483 - Kat Implants, LLC - September 16, 2022

During an FDA inspection conducted from September 13 to September 16, 2022, dental implant manufacturer Kat Implants, LLC received a Form FDA 483 detailing significant observations related to its quality management system. The primary issues identified involved inadequately maintained complaint files and device history records. For complaint handling, the company was not adhering to its own standard operating procedures, instead tracking complaints via Corrective and Preventive Action (CAPA) forms. This practice led to insufficient documentation, including missing lot numbers and a failure to gather necessary information on patient injuries or illnesses associated with device failures, which is critical for determining mandatory adverse event reporting to the FDA. Additionally, the device history records were found to be deficient, with numerous records lacking essential finished device documentation as required by the firm's internal procedures. Kat Implants, LLC also had not implemented the Unique Device Identifier (UDI) requirements in its DHRs. The firm is required to address these observations by implementing corrective actions to ensure compliance with quality system regulations governing complaint handling, adverse event evaluation, and comprehensive device history record maintenance.