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745586

Omega Medical Imaging, Inc. — FEI 1000222289

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 19, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Compliance: Devices
Location
Sanford, FL (United States)

Facility

Other inspections at this facility

  • 1287420 (NAI Mon Sep 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1178285 (NAI Fri Aug 26 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1072961 (VAI Wed Nov 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1004455 (NAI Fri Feb 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 894276 (VAI Fri Sep 05 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
313021 CFR 820.100(a)Lack of or inadequate procedures