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1283842

Nelson Laboratories, LLC — FEI 3000717698

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 26, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Itasca, IL (United States)

Facility

Other inspections at this facility

  • 1073798 (NAI Thu Nov 08 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 961743 (VAI Fri Mar 11 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 835477 (NAI Wed Jun 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 759436 (NAI Wed Dec 07 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 684290 (NAI Fri Oct 08 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
127021 CFR 211.68(b)input/output verification
191821 CFR 211.166(a)(2)Stability sample storage conditions described
361521 CFR 211.160(b)(4)Test devices not meeting specifications