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1238748

Alphapharm Pty, Ltd. — FEI 3002806388

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 28, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Carole Park (Australia)

Facility

Other inspections at this facility

  • 1236816 (NAI Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1111818 (NAI Thu Oct 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1029077 (NAI Fri Sep 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 936225 (NAI Thu Jul 02 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 844498 (VAI Thu Jul 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified