FDA 483 - Zyno Medical LLC - August 16, 2023

Zyno Medical LLC, a manufacturer of infusion pumps in Natick, MA, was cited with four observations during an FDA inspection. The firm failed to adequately establish CAPA procedures, investigate complaints in a timely manner, and submit Medical Device Reports within the required timeframe. Additionally, management did not review the quality system at defined intervals, indicating significant deficiencies in their quality management system.