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Compliance actions
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Warning Letter
Case 629844 — FEI 3006575795
Facility
Facility 3006575795
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
Warning Letter (507058)
(Mon Dec 05 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
Action Details
Facility
Zyno Medical LLC
Date
July 12, 2022
Fiscal Year
2022
Product Type
Devices
Center
CDRH
Location
Natick, MA (United States)