FDA 483 - Inspire Medical Systems Inc. - May 10, 2024

During an inspection conducted from April 16 to May 10, 2024, Inspire Medical Systems Inc. received an FDA Form 483 citing several objectionable conditions related to its medical device manufacturing operations. The observations highlight failures to adequately implement and maintain quality system procedures. Specifically, the FDA noted deficiencies in the company's purchasing controls and supplier management, including inadequate validation of sterilization processes and lack of documentation for equipment equivalency at contract manufacturers. The firm also failed to properly investigate complaints involving potential device failures, particularly multiple instances of patient infections, often concluding root causes without sufficient supporting evidence. Furthermore, Inspire Medical Systems Inc. was cited for inadequately established Corrective and Preventive Action (CAPA) procedures. This included pending implementations for critical issues like mismatched serial numbers on product labels, and incomplete assessments of root causes in other CAPAs. Finally, the inspection revealed shortcomings in procedures for monitoring and controlling process parameters, specifically concerning the handling and testing timelines for bioburden and endotoxin samples. The company has committed to correcting all identified observations to ensure compliance with FDA quality system regulations.