FDA 483 - Atrium Medical Corporation - November 26, 2024

Atrium Medical Corporation received an FDA Form 483 citing significant quality system deficiencies across multiple areas. The inspection revealed inadequate design verification for their iCast and Advanta V12 stents, leading to component separation and patient deaths, alongside failures in environmental controls and nonconforming product procedures for various sterile medical devices. Furthermore, the firm demonstrated systemic issues with its corrective and preventive action system, and critically, failed to timely investigate and report numerous complaints and Medical Device Reports (MDRs) related to serious injuries and device malfunctions.