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1257835

Mayne Pharma International PTY LTD — FEI 3004090027

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 21, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Salisbury South (Australia)

Facility

Other inspections at this facility

  • 1110711 (VAI Fri Oct 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1035729 (NAI Fri Sep 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 945811 (VAI Fri Sep 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 846520 (VAI Fri Aug 02 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 588986 (VAI Fri May 15 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
136121 CFR 211.100(a)Absence of Written Procedures
360321 CFR 211.160(b)Scientifically sound laboratory controls
434221 CFR 211.142(b)Storage under appropriate conditions