Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistEnvoy Medical Inc. was cited for manufacturing the Esteem II Implantable Hearing System in violation of FDA's Quality System Regulation (21 CFR Part 820), with the device deemed adulterated due to inadequate manufacturing controls and practices. The inspection conducted from June 24-July 2, 2025, identified failure to adequately establish and maintain complaint handling procedures through a formally designated unit, including improper processing of complaints such as one documenting device explantation due to patient infection in November 2024. The company's response to the FDA 483 observations issued during the inspection was found inadequate to address the systemic compliance gaps in their quality management system.