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483
•Zyno Medical LLC•September 18, 2025

FDA 483 - Zyno Medical LLC - September 18, 2025

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Record Details

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.

Company
Zyno Medical LLC
Inspection Date
September 18, 2025
Product Type
Device
Office
New England District Office
Person
  • Nabil Nakhoul
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ID · 465d5a17-4f0b-47b1-af1f-dbc2133882d3

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