FDA 483 - Atrium Medical Corporation - February 10, 2020

Atrium Medical Corporation in Merrimack, NH, was cited with six observations during an FDA inspection, indicating significant deficiencies in its quality system. The firm failed to adequately address issues related to design verification, process validation, corrective and preventive actions, and nonconforming product disposition. Additionally, complaint investigations and personnel training procedures were found to be inadequate, highlighting a need for comprehensive improvements in their medical device manufacturing and quality control processes.