483
Zyno Medical LLCFDA 483 - Zyno Medical LLC - September 18, 2025
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Zyno Medical LLC, a medical device manufacturer in Natick, MA, received a Form FDA 483 with one repeat observation. The firm failed to submit 60 Medical Device Reports (MDRs) within the required 30-day timeframe, indicating a significant issue with their reporting procedures for device malfunctions. This is a repeat observation, highlighting a persistent compliance problem.
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