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983260

The Mentholatum Company — FEI 3000717606

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 27, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Orchard Park, NY (United States)

Facility

Other inspections at this facility

  • 1231878 (NAI Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1146184 (VAI Thu Jun 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1132758 (NAI Tue Oct 27 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1095881 (VAI Tue Jul 09 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1009228 (NAI Wed Apr 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
188321 CFR 211.165(a)Testing and release for distribution
8935FDCA 760(b)(1)Failure of responsible person to report AE (non-RX Drug)