FDA 483 - Atrium Medical Corporation - August 02, 2018

The FDA inspection of Atrium Medical Corporation in Merrimack, NH, revealed critical deficiencies in their quality system, particularly concerning the manufacture of iCAST/V12 vascular stents. The firm failed to adequately control bacterial endotoxin and bioburden contamination, validate processes, and document corrective and preventive actions. Additionally, issues were noted with equipment calibration and the timely submission of Medical Device Reports for injuries and malfunctions.