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1115289

Ultradent Products, Inc. — FEI 1718912

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 17, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
South Jordan, UT (United States)

Facility

Other inspections at this facility

  • 1272589 (VAI Fri Jun 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1086182 (NAI Thu Mar 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1025250 (VAI Fri Sep 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 895359 (VAI Fri Sep 12 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 854539 (NAI Fri Nov 08 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
180921 CFR 211.160(a)Following/documenting laboratory controls
189021 CFR 211.165(e)Test methods
360321 CFR 211.160(b)Scientifically sound laboratory controls