Home / Inspections / 958930

958930

JCB Laboratories LLC — FEI 3004839646

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 3, 2015
Fiscal Year
2016
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))
  • 818211 (OAI Wed Feb 27 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
18009FDCA 503B(a)(10)Container label, outsourcer facility
202721 CFR 211.192Investigations of discrepancies, failures
220521 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
360321 CFR 211.160(b)Scientifically sound laboratory controls