Home / Inspections / 1271571

1271571

Bell Pharmaceuticals, Inc — FEI 2123499

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 18, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Belle Plaine, MN (United States)

Facility

Other inspections at this facility

  • 1047160 (VAI Fri Apr 06 2018 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
104921 CFR 211.22(a)Approve or reject components, products
117721 CFR 211.63Equipment Design, Size and Location
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
139521 CFR 211.103Actual vs. theoretical yields not determined
360321 CFR 211.160(b)Scientifically sound laboratory controls
440221 CFR 211.192Written record of investigation incomplete