Home / Inspections / 835523

835523

Septodont Inc. — FEI 1721729

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 12, 2013
Fiscal Year
2013
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))
  • 1032021 (VAI Wed Nov 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 885442 (VAI Mon May 19 2014 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
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
108621 CFR 211.22(b)Adequate lab facilities not available
110521 CFR 211.22(d)Procedures not in writing, fully followed
194321 CFR 211.180(e)(1)Review of representative number of batches
354721 CFR 211.46(b)Equipment for Environmental Control
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified