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1115304

Radiology Information Systems, Inc. — FEI 3002952981

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 17, 2020
Fiscal Year
2020
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))
  • 963571 (VAI Wed Mar 09 2016 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
1472221 CFR 820.40Procedures not adequately established or maintained
2142521 CFR 820.184(f)DHR - UDI not included
232821 CFR 820.22Quality audits - auditor independence
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
367721 CFR 820.30(g)Design validation - software validation not performed
369621 CFR 820.100(b)Documentation