483
Zyno Medical LLCFDA 483 - Zyno Medical LLC - August 16, 2023
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Record Details
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.
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