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772058

Crown Laboratories — FEI 1019820

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 9, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
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
176721 CFR 211.137(a)Expiration date lacking
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
358521 CFR 211.110(a)Control procedures to monitor and validate performance
361621 CFR 211.165(d)Acceptance criteria for sampling & testing
430321 CFR 211.67(b)Written procedures fail to include
432521 CFR 211.110(a)Control procedures fail to include the following