FDA 483 - Zyno Medical LLC - September 18, 2025

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.