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1032021

Septodont Inc. — FEI 1721729

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 22, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Louisville, CO (United States)

Facility

Other inspections at this facility

  • 1120878 (NAI Mon Feb 10 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 885442 (VAI Mon May 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 835523 (VAI Wed Jun 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 741773 (VAI Thu Aug 25 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 663400 (NAI Wed Apr 14 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
108621 CFR 211.22(b)Adequate lab facilities not available
154021 CFR 211.125(a)Strict control not exercised over labeling issued
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified