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1099061

Protek Medical Products Inc — FEI 3001701594

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 8, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Coralville, IA (United States)

Facility

Other inspections at this facility

  • 989313 (NAI Thu Oct 06 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 863555 (VAI Tue Jan 21 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 598379 (NAI Tue Jul 21 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
53921 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
63321 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports