FDA 483 - Gyrus ACMI, Inc. - November 02, 2026

During an inspection conducted from October 26 to November 2, 2023, Gyrus ACMI, Inc., a medical device manufacturer located in Littleton, MA, received an FDA Form 483 citing significant quality system deficiencies. The inspection revealed three primary observations indicating non-compliance with established regulatory requirements for device manufacturing. Firstly, the company failed to adequately maintain device history records. Specific instances included releasing medical devices, such as the Easy Suite 4k and nCare, without completing all required documentation, including quality approvals, test acceptance plans, acceptance records, and final inspection records, as mandated by their internal procedures. One such release was associated with a reportable complaint. Secondly, Gyrus ACMI’s complaint handling procedures were found to be inadequate. The firm did not consistently adhere to its 60-day target for closing complaints, with a substantial number of complaints, including those related to reportable events, experiencing significant delays and lack of activity. Additionally, the company failed to thoroughly record complaint details and initiate investigations promptly, leading to delayed reporting of adverse events. Finally, the procedures for corrective and preventive actions (CAPA) were not adequately established or followed. The company failed to properly execute and verify the effectiveness of its corrective actions according to its own plans. Examples included insufficient scope in verification activities for cable failure CAPA and premature completion of verification for a complaint timeliness CAPA, deviating from the required timeline. Gyrus ACMI is required to address these observations by implementing comprehensive corrective actions to ensure compliance with quality system regulations.