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1178803

Massco Dental — FEI 3001238690

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 2, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Rogers, AR (United States)

Facility

Other inspections at this facility

  • 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))
  • 695768 (VAI Fri Oct 29 2010 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
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
145021 CFR 211.113(a)Procedures for non-sterile drug products
188521 CFR 211.165(b)Microbiological testing
356721 CFR 211.84(d)(2)Component identification test
358521 CFR 211.110(a)Control procedures to monitor and validate performance
457621 CFR 211.192No written record of investigation
900121 CFR 211.22(a)Lack of quality control unit