FDA 483 - Exotoe LLC - November 21, 2024

Exotoe LLC, a specification developer in Charlotte, NC, was cited for significant deficiencies across its quality system during an FDA inspection. Observations included inadequate design validation for its ExoToe Plate and Forceps, issues with device history records for Class II toe implants, and failures in establishing proper procedures for design transfer, corrective and preventive actions, and finished device acceptance. These issues indicate a lack of robust controls over product design, manufacturing, and quality management.