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550852

CliniSys, Inc — FEI 1000306472

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 14, 2008
Fiscal Year
2009
Product Type
Devices
Project Area
Compliance: Devices
Location
Tucson, AZ (United States)

Facility

Other inspections at this facility

  • 1215144 (NAI Thu Jul 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 915421 (NAI Thu Feb 26 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 735003 (NAI Fri Jul 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
329921 CFR 820.100(a)(1)Procedure for analysis of data sources
330421 CFR 820.100(a)(5)Changes to correct/prevent quality problems
339821 CFR 820.80(d)(3)No release signature
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures