Home / Inspections / 1118264

1118264

Abraxis Bioscience, LLC — FEI 3006441852

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 19, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Phoenix, AZ (United States)

Facility

Other inspections at this facility

  • 1220002 (VAI Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1166508 (OAI Wed Apr 06 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062643 (VAI Fri Aug 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 987449 (VAI Fri Jun 24 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 890300 (VAI Fri Aug 08 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
135821 CFR 211.100(b)SOPs not followed / documented
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
440221 CFR 211.192Written record of investigation incomplete