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866595

Crown Laboratories — FEI 1019820

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 14, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Unapproved and Misbranded Drugs
Location
Johnson City, TN (United States)

Facility

Other inspections at this facility

  • 1254956 (VAI Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1050586 (NAI Thu Mar 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1045454 (NAI Thu Feb 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 973822 (VAI Fri Apr 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 898298 (OAI Wed Sep 24 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

  • Injunction (47) (Tue Jul 25 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
162621 CFR 211.130Procedures are written, and followed
180921 CFR 211.160(a)Following/documenting laboratory controls
189021 CFR 211.165(e)Test methods
191221 CFR 211.166(a)Written program not followed
432521 CFR 211.110(a)Control procedures fail to include the following