FDA 483 - Atrium Medical Corporation - October 01, 2013

An FDA inspection of Atrium Medical Corporation in Hudson, NH, revealed multiple significant deficiencies in their quality system for medical device manufacturing. The firm failed to adequately validate processes, monitor validated parameters, and establish effective corrective and preventive actions. Additionally, the company did not submit required Medical Device Reports (MDRs) within the mandated timeframe and maintained inadequate complaint files.