FDA 483 - Atrium Medical Corporation - July 13, 2016

Atrium Medical Corporation received a Form 483 citing significant deficiencies across multiple quality system areas. The observations primarily focused on inadequate validation of sterilization and manufacturing processes for devices like iCAST/V12 stents and chest drains, as well as failures in design verification, packaging integrity, and shelf-life studies. Additionally, the firm demonstrated systemic issues with its corrective and preventive action system, control of non-conforming product, equipment maintenance, complaint handling, and timely submission of Medical Device Reports for serious injuries and malfunctions.