FDA 483 - Zyno Medical LLC - February 15, 2022

An FDA inspection of Zyno Medical LLC in Natick, MA, a manufacturer of infusion pumps and administration sets, revealed significant deficiencies across its quality system. The firm failed to adequately establish procedures for design changes, control non-conforming products, implement corrective and preventive actions, and properly handle complaints. Additionally, issues were noted in supplier evaluation and timely submission of Medical Device Reports.