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1203866

Allison Medical, Inc. — FEI 1000138447

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
April 28, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Littleton, CO (United States)

Facility

Other inspections at this facility

  • 1175810 (VAI Fri Jul 29 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 991305 (VAI Wed Oct 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 811431 (VAI Mon Dec 10 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1472221 CFR 820.40Procedures not adequately established or maintained
311721 CFR 820.70(i)Software validation for automated processes
313021 CFR 820.100(a)Lack of or inadequate procedures
64421 CFR 803.18(b)(1)(ii)Files do not contain copies of MDR reports