INSPIRE MEDICAL SYSTEMS INC – FDA 483, Dec 19, 2025
An FDA inspection of INSPIRE MEDICAL SYSTEMS INC in Golden Valley, MN, revealed significant deficiencies in their complaint handling system. The firm failed to adequately establish and implement procedures for receiving, reviewing, and evaluating complaints, particularly regarding Medical Device Reporting (MDR) rationale for patient deaths. Additionally, complaint investigations for patient deaths lacked adequate documentation, and complaints were not processed uniformly or in a timely manner.
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