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865806

Playtex Manufacturing, Inc. — FEI 3000717960

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 6, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Sidney, OH (United States)

Facility

Other inspections at this facility

  • 1266386 (VAI Mon Apr 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102055 (VAI Fri Sep 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 718235 (VAI Wed Feb 23 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
113621 CFR 211.25(c)Inadequate number of personnel
117721 CFR 211.63Equipment Design, Size and Location
126321 CFR 211.68(b)Computer control of master formula records
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
180121 CFR 211.84(a)Components withheld from use pending release
189121 CFR 211.165(f)Failing drug products not rejected
202721 CFR 211.192Investigations of discrepancies, failures
241921 CFR 211.198(a)Complaint Handling Procedure
357321 CFR 211.101(b)Measured components for manufacturing
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls