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1251720

EyeKon Medical, Inc. — FEI 1038833

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 10, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Clearwater, FL (United States)

Facility

Other inspections at this facility

  • 1042012 (VAI Fri Feb 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 809132 (VAI Wed Nov 28 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 588902 (NAI Fri Jun 12 2009 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 540097 (OAI Fri Oct 03 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
342721 CFR 820.50(a)(2)Supplier oversight