Inspire Medical Corp. – FDA EIR, May 10, 2024

Inspire Medical Corp. underwent a routine FDA surveillance inspection from April 16 to May 10, 2024, focusing on its Upper Airway Stimulation (UAS) device. The inspection, conducted under the framework for Medical Device Manufacturers, resulted in a 4-item FDA 483, "Inspectional Observations," and two verbal observations.

Major violations, citing 21 CFR 820.50, 820.198(c), and 820.100(a), included deficiencies in purchasing controls. Specifically, the firm failed to adequately validate sterilization processes and welding equipment equivalency at contract manufacturers, raising concerns about product sterility and integrity. Complaint handling procedures were found inadequate, with a lack of proper investigation into potential sources of contamination for infection-related complaints and insufficient documentation for others. Corrective and Preventive Action (CAPA) procedures were also deficient, characterized by actions not commensurate with risk, incomplete root cause analyses, and delays in implementation. Additionally, issues were noted in process monitoring controls related to sterilization sample handling. Verbal observations highlighted potential underreporting of Medical Device Reports (MDRs) and an unclear, untimely corrections and removals process.

Inspire Medical Corp. indicated its intent to provide a voluntary written response outlining corrective actions and timeframes. The findings underscore the need for robust quality system implementation, especially given the implantable nature of their device.