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963571

Radiology Information Systems, Inc. — FEI 3002952981

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 9, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Compliance: Devices
Location
Dulles, VA (United States)

Facility

Other inspections at this facility

  • 1273089 (NAI Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1115304 (VAI Fri Jan 17 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 935768 (VAI Wed Jul 15 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
232821 CFR 820.22Quality audits - auditor independence
265021 CFR 820.30(f)Design verification - Lack of or inadequate procedures
367721 CFR 820.30(g)Design validation - software validation not performed