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1034510

LEC Custom Products, Inc. — FEI 3004737602

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 8, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Brampton (Canada)

Facility

Other inspections at this facility

  • 1120203 (OAI Fri Mar 06 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 922379 (VAI Fri Mar 27 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 760757 (VAI Thu Dec 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
136121 CFR 211.100(a)Absence of Written Procedures
141321 CFR 211.42(c)(5)Mfg / Processing Operations Area
191421 CFR 211.166(a)Lack of written stability program
202721 CFR 211.192Investigations of discrepancies, failures
358121 CFR 211.101(d)Verification of component addition
359221 CFR 211.110(c)In-process materials characteristics testing
431521 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs