FDA 483 - Masterbilt Incorporated - June 21, 2024

During an inspection conducted from June 17-21, 2024, the FDA issued a Form 483 to Masterbilt Incorporated, a medical device manufacturer in South Bend, IN. The inspection revealed significant deviations from quality system requirements. Key observations focused on the firm's cleaning processes, which lacked adequate validation, consistent execution according to established procedures, and proper monitoring of critical parameters. Further issues included deficiencies in the control of non-conforming products, with multiple instances of incomplete records, missing dispositions, and insufficient documentation of rework and re-inspection. The firm's corrective and preventive action (CAPA) system also exhibited shortcomings, including incomplete documentation, lack of effectiveness evaluations, and inadequate tracking of CAPA records. Additionally, the FDA noted insufficient schedules for equipment maintenance, specifically for the cleaning system, leading to undocumented checks and solution changes. Finally, device history records were found to be inadequately maintained, missing essential documents like control plans and primary identification labels. Masterbilt Incorporated is required to address these observations by implementing comprehensive corrective actions to ensure full compliance with FDA's Quality System Regulation for medical devices.