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897811

Estee Lauder Cosmetics Ltd. — FEI 3000248560

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 19, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Scarborough (Canada)

Facility

Other inspections at this facility

  • 1198594 (VAI Fri Feb 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1027659 (VAI Fri Sep 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 777706 (VAI Thu Jan 26 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
113321 CFR 211.25(a)GMP Training Frequency
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
180921 CFR 211.160(a)Following/documenting laboratory controls
194321 CFR 211.180(e)(1)Review of representative number of batches
197521 CFR 211.182Written records kept in individual logs
202621 CFR 211.192Quality control unit review of records
202721 CFR 211.192Investigations of discrepancies, failures
202821 CFR 211.192Extent of discrepancy, failure investigations
241921 CFR 211.198(a)Complaint Handling Procedure
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
360321 CFR 211.160(b)Scientifically sound laboratory controls