FDA 483 - Zyno Medical LLC - August 16, 2023

An FDA inspection of Zyno Medical LLC in Natick, MA, conducted from June 21 to August 16, 2023, identified significant deficiencies within the company's quality management system. The FDA Form 483 report highlighted four primary observations, three of which were repeat findings, indicating ongoing non-compliance with regulatory requirements for medical device manufacturers.

Key violations included inadequate procedures for corrective and preventive actions (CAPAs). Zyno Medical failed to analyze and evaluate 503 infusion pump complaints (involving leaking, power, battery, flow rate, and air in line issues) reported since February 2022, and did not link them to open CAPAs. The firm also failed to timely investigate 140 of 286 complaints, exceeding its internal closure objectives. Furthermore, Zyno Medical did not submit 43 of 87 Medical Device Reports (MDRs) within the required timeframe for malfunctions like broken filters and leaking complaints, with some reports delayed by eight months. Lastly, executive management failed to regularly review the suitability and effectiveness of the quality system, missing all scheduled reviews for 2023 and conducting only one in 2022. Zyno Medical has committed to correcting these observations, which will require comprehensive actions to bring its quality system into full compliance.