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1146184

The Mentholatum Company — FEI 3000717606

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 17, 2021
Fiscal Year
2021
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))
  • 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))
  • 983260 (VAI Fri May 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
355321 CFR 211.48(a)Plumbing System Defects
435521 CFR 211.165(c)Sampling and testing plans not followed
8938FDCA 760(c)(1)Timing of AE report submission (non-RX drugs)