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

Inspire Medical Systems Inc. in Golden Valley, MN, was cited for four observations during an FDA inspection. The firm failed to adequately establish procedures for purchasing controls, supplier management, and corrective and preventive actions. Additionally, complaint investigations for potential device failures, especially infections, were not adequately conducted, and procedures for monitoring process parameters for validated processes were inadequately defined and implemented.