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818211

JCB Laboratories LLC — FEI 3004839646

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 27, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Wichita, KS (United States)

Facility

Other inspections at this facility

  • 1069957 (OAI Fri Sep 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 958930 (VAI Thu Dec 03 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
191421 CFR 211.166(a)Lack of written stability program
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
360321 CFR 211.160(b)Scientifically sound laboratory controls