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997053

Avanti Polar Lipids — FEI 1036868

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 14, 2016
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Alabaster, AL (United States)

Facility

Other inspections at this facility

  • 1209583 (VAI Fri Jul 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 923732 (VAI Wed Apr 15 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 812084 (NAI Wed Dec 05 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 714559 (NAI Wed Mar 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 710055 (NAI Mon Feb 14 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
110521 CFR 211.22(d)Procedures not in writing, fully followed
142021 CFR 211.42(c)(9)Control / Lab Operations Area
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
358521 CFR 211.110(a)Control procedures to monitor and validate performance
430621 CFR 211.80(a)Written Procedures Not Followed
447921 CFR 108.25(e)Recall procedures