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Warning Letter

Case 507058 — FEI 3006575795

Facility

Recent inspections

  • 1241357 (VAI Thu Sep 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1215340 (OAI Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1162461 (OAI Tue Feb 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1035238 (VAI Fri Dec 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 981584 (OAI Thu Aug 11 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Other compliance actions

Action Details

Facility
Zyno Medical LLC
Date
December 5, 2016
Fiscal Year
2017
Product Type
Devices
Center
CDRH
Location
Natick, MA (United States)