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1158719

Primrose Candy Co. — FEI 1412287

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 19, 2021
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chicago, IL (United States)

Facility

Other inspections at this facility

  • 1135999 (VAI Thu Feb 25 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1026834 (VAI Tue Sep 26 2017 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
139521 CFR 211.103Actual vs. theoretical yields not determined
150521 CFR 211.122(d)Label storage access limited to authorized personnel
191421 CFR 211.166(a)Lack of written stability program
194221 CFR 211.180(e)Records reviewed annually
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
357021 CFR 211.100(a)Approval and review of procedures
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
363221 CFR 211.170(b)Annual visual exams of drug products
431421 CFR 211.84(d)(2)Reports of Analysis (Components)