FDA 483 - Exotoe LLC - November 21, 2024

An FDA inspection of ExoToe LLC, with Kapstone Medical also listed, in Charlotte, NC, was conducted from November 14 to November 21, 2024. The inspection revealed several significant observations indicating non-compliance with the Quality System Regulation for medical devices. Key issues included inadequate design validation, where simulated use conditions for toe implants lacked sufficient justification for model material appropriateness. The firm's device history records demonstrated inconsistencies, such as discrepancies in manufacturing quantities, incorrect lot numbering on product labeling, and missing in-process inspection records. Additionally, procedures for design transfer were not adequately established, specifically regarding specifications for incoming raw materials like stainless-steel. The inspection also highlighted untimely corrective and preventive action (CAPA) investigations, with two CAPAs only being closed after the inspection announcement. Lastly, deficiencies were noted in finished device acceptance procedures, as device history records were found to be incomplete, lacking essential manufacturing details. ExoToe LLC is required to address these findings by developing and implementing comprehensive corrective actions to ensure full regulatory compliance.