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1010063

AlloSource — FEI 3000215346

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 9, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Centennial, CO (United States)

Facility

Other inspections at this facility

  • 1201259 (NAI Thu Mar 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1175639 (NAI Wed Jul 27 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1074854 (NAI Tue Dec 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 929703 (VAI Thu Jun 11 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 781336 (VAI Mon Jun 04 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1234321 CFR 1271.190(a)State of repair
1238721 CFR 1271.220(a)Causing contamination, increasing risks
1239921 CFR 1271.230(a)Process validation procedures
1241121 CFR 1271.260(a)Contamination, mix ups, improper release
311721 CFR 820.70(i)Software validation for automated processes
53721 CFR 820.70(a)Production processes
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation