FDA EIR - Exactech, Inc. - January 31, 2020

Exactech, Inc., a manufacturer of various medical implants (Class 2 and 3), underwent an FDA "For Cause" inspection in Gainesville, FL, from January 27-31, 2020. This inspection aimed to evaluate corrective actions for issues identified in a previous 2017 inspection and to follow up on product recalls. The regulatory scope covered corrective and preventive action (CAPA), process control, and design control, aligning with the FDA's Quality System Regulation for medical devices. The inspection revealed significant deficiencies across multiple areas. Pervasive issues with the CAPA system included inadequate root cause investigations for recalls (e.g., Optetrak Logic Stem Extension and Opteform bone filler temperature excursion), failure to verify effectiveness of field actions, and lack of updated design documentation for product modifications. Supplier quality management procedures were found insufficient in addressing validation of automated processes and identifying all critical supplier processes. Design validation for instruments did not account for potential misuse, and nonconforming product handling procedures were not consistently followed, including timely documentation and physical segregation of affected products. Further design control issues involved a lack of physical confirmation for screw compatibility changes in an offset tibial tray system and incomplete design transfer documentation regarding supplier manufacturing procedures. Lastly, Process Failure Modes & Effects Analyses (PFMEA) lacked identification of all necessary process controls for risk mitigation. An FDA Form 483 was issued, requiring Exactech to address these systemic quality and compliance failures.