Home / Inspections / 1012817

1012817

Caliber Imaging and Diagnostics, Inc. — FEI 3001451602

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 1, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Rochester, NY (United States)

Facility

Other inspections at this facility

  • 1260155 (VAI Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1167844 (NAI Mon Apr 18 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1106559 (NAI Thu Oct 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 618535 (VAI Fri Aug 07 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
265021 CFR 820.30(f)Design verification - Lack of or inadequate procedures
311721 CFR 820.70(i)Software validation for automated processes
313021 CFR 820.100(a)Lack of or inadequate procedures
367721 CFR 820.30(g)Design validation - software validation not performed