Inspire Medical Systems Inc. – FDA EIR, Sep 16, 2021

An FDA compliance follow-up inspection of Inspire Medical Systems, Inc., a manufacturer of the Inspire II Upper Airway Stimulation device, was conducted from September 2-16, 2021. The inspection aimed to verify corrective actions implemented by the company following findings from a previous inspection in June 2018. During the 2018 inspection, the company received observations for failing to submit Medical Device Reports (MDRs) within the required 30-day timeframe and for inadequate documentation of supplier Corrective and Preventive Actions (CAPAs). Additional verbal observations included insufficient management resources, inadequate risk management procedures, and unreported international recalls. In this follow-up inspection, conducted under FDA's Medical Device Level III Compliance Follow-up and Comprehensive QSIT programs, the FDA confirmed that Inspire Medical Systems had successfully implemented corrective measures for the previously identified issues, including establishing an electronic MDR process and enhancing supplier CAPA documentation. Consequently, no new formal observations (FDA-483) were issued. However, the inspection resulted in a verbal recommendation for the company to improve the timeliness of closing CAPAs and customer complaints. Management acknowledged and accepted this recommendation, indicating ongoing efforts to address these areas.