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1026834

Primrose Candy Co. — FEI 1412287

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 26, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chicago, IL (United States)

Facility

Other inspections at this facility

  • 1158719 (VAI Fri Nov 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1135999 (VAI Thu Feb 25 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 974328 (NAI Tue Apr 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 791475 (VAI Wed Jul 25 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 701123 (VAI Wed Dec 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
191421 CFR 211.166(a)Lack of written stability program
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action