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695768

Massco Dental — FEI 3001238690

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 29, 2010
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Rogers, AR (United States)

Facility

Other inspections at this facility

  • 1178803 (OAI Fri Sep 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 990480 (VAI Thu Aug 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 887950 (VAI Fri Jul 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 574456 (NAI Wed Apr 08 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
113321 CFR 211.25(a)GMP Training Frequency
136121 CFR 211.100(a)Absence of Written Procedures
191721 CFR 211.166(a)(1)Sample size - test intervals
200421 CFR 211.184(d)Labeling: documentation of exam and review
200921 CFR 211.188Prepared for each batch, include complete information
435021 CFR 211.160(b)(3)Drug products-sampling procedures/specifications