FDA 483 - Gyrus ACMI, Inc. - November 02, 2023

An FDA inspection of Gyrus ACMI, Inc. in Littleton, MA, revealed significant deficiencies in their quality system for medical device manufacturing. The firm failed to adequately maintain device history records, establish proper complaint handling procedures, and effectively implement corrective and preventive actions. These issues indicate a systemic breakdown in ensuring device quality and regulatory compliance.