FDA 483 - Mako Surgical Corporation - February 23, 2018

An FDA inspection of Mako Surgical Corporation in Davie, FL, revealed two significant issues. The firm failed to adequately document corrective and preventive action (CAPA) activities, specifically regarding the verification and validation of planned actions. Additionally, procedures for ensuring purchased products conform to requirements were not fully implemented, as evidenced by missing supplier documentation for a contract manufacturer.