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826998

Bell Pharmaceuticals, Inc — FEI 2123499

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 5, 2013
Fiscal Year
2013
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))
  • 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))
  • 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
150521 CFR 211.122(d)Label storage access limited to authorized personnel
200921 CFR 211.188Prepared for each batch, include complete information
8935FDCA 760(b)(1)Failure of responsible person to report AE (non-RX Drug)