FDA 483 - Motion Concepts LP - November 16, 2023

During an FDA inspection conducted from November 13-16, 2023, medical device manufacturer Motion Concepts LP received a Form FDA 483 citing three significant observations related to its quality management system. The inspection revealed deficiencies in the documentation of corrective and preventive action (CAPA) activities and results. Specifically, CAPA 0192, related to a recurring broken frame issue with nine customer complaints, was deemed inadequate as its associated risk analysis indicated potential safety concerns that were not clearly addressed with further evaluation. Additionally, Motion Concepts LP was cited for failing to adequately establish requirements for its suppliers. A critical supplier was incorrectly classified as low risk, leading to less robust monitoring than required by the company's own procedures. The inspection also identified inadequacies in the firm's risk analysis processes, where subjective probability scoring for hazards could lead to inconsistent risk level calculations. These observations indicate potential non-compliance with quality system regulations for medical devices. Motion Concepts LP has acknowledged these findings and committed to correcting all identified issues.