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1251914

Glottal Enterprises Inc. — FEI 1319182

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 17, 2024
Fiscal Year
2025
Product Type
Devices
Project Area
Compliance: Devices
Location
Syracuse, NY (United States)

Facility

Other inspections at this facility

  • 1120569 (NAI Fri Mar 06 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 996504 (NAI Tue Dec 13 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 852562 (VAI Wed Oct 09 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 804076 (OAI Thu Oct 18 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
2142521 CFR 820.184(f)DHR - UDI not included
2280221 CFR 830.320(a)GUDID Designation of contact for device identification.
333121 CFR 820.181DMR - not or inadequately maintained
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures