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1035238

Zyno Medical LLC — FEI 3006575795

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 15, 2017
Fiscal Year
2018
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Natick, MA (United States)

Facility

Other inspections at this facility

  • 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))
  • 981584 (OAI Thu Aug 11 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 795500 (VAI Wed Aug 22 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471721 CFR 820.30(g)Design validation - software validation documentation
73221 CFR 803.50(a)(2)Individual Report of Malfunction