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1272589

Ultradent Products, Inc. — FEI 1718912

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 13, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
South Jordan, UT (United States)

Facility

Other inspections at this facility

  • 1115289 (VAI Fri Jan 17 2020 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
121521 CFR 211.67(b)Written procedures not established/followed
360321 CFR 211.160(b)Scientifically sound laboratory controls
457621 CFR 211.192No written record of investigation