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1220002

Abraxis Bioscience, LLC — FEI 3006441852

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 6, 2023
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Phoenix, AZ (United States)

Facility

Other inspections at this facility

  • 1166508 (OAI Wed Apr 06 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118264 (VAI Wed Feb 19 2020 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
127021 CFR 211.68(b)input/output verification
143621 CFR 211.42(c)(10)(vi)Equipment to control conditions
363221 CFR 211.170(b)Annual visual exams of drug products
440221 CFR 211.192Written record of investigation incomplete
441321 CFR 211.194(a)(8)Second person sign off