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1047160

Bell Pharmaceuticals, Inc — FEI 2123499

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 6, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Belle Plaine, MN (United States)

Facility

Other inspections at this facility

  • 1271571 (VAI Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 955992 (VAI Fri Nov 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 826998 (VAI Fri Apr 05 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 697960 (NAI Fri Nov 12 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 582576 (VAI Fri May 15 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
141821 CFR 211.42(c)(7)Quarantined Drug Products Area
187921 CFR 211.180(c)Records not made readily available to FDA
192021 CFR 211.166(a)(3)Valid stability test methods
434221 CFR 211.142(b)Storage under appropriate conditions