FDA EIR - Inspire Medical Systems Inc. - June 22, 2018

Inspire Medical Systems Inc., a manufacturer of the Inspire II Upper Airway Stimulation device, underwent an FDA inspection from June 18-22, 2018. The inspection followed Compliance Program 7382.845 for Medical Device Manufacturers and utilized the Quality System Inspection Technique (QSIT). The FDA issued Form FDA-483, highlighting two significant observations and several verbal concerns. The primary violations included a failure to submit Medical Device Reports (MDRs) within the regulatory 30-day timeframe, with numerous instances showing delays of up to 213 days. This issue was partly attributed to insufficient management resources. Additionally, the company failed to adequately document supplier Corrective and Preventive Actions (CAPAs), with several examples lacking proper corrective action plans, implementation evidence, or timely responses, as required by their own procedures, referencing 21 CFR 803.50(a)(1) and 21 CFR 820.100(b). Verbal observations noted during the inspection included the identified resource constraints impacting regulatory filings, and inconsistencies between CAPA risk analyses and the firm's Risk Management Procedure, which failed to clearly define when field corrective actions were necessary. Furthermore, an international recall for a CE-approved product was not reported to the FDA, a regulatory requirement. Discussions also raised concerns about the device's labeling not explicitly listing "stroke symptoms" as a potential adverse event, despite patient reports, which the company categorized as "Neuropraxia." Inspire Medical Systems Inc. acknowledged the issues and committed to addressing the observations, implying required corrective actions to meet regulatory compliance.