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1283762

Frontida Biopharm, LLC — FEI 3008087151

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 24, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Aurora, IL (United States)

Facility

Other inspections at this facility

  • 1137467 (NAI Fri Feb 26 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 961359 (NAI Thu Feb 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 820917 (NAI Tue Feb 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 739828 (NAI Tue Aug 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 637304 (NAI Tue Jan 05 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
135821 CFR 211.100(b)SOPs not followed / documented
358521 CFR 211.110(a)Control procedures to monitor and validate performance
900121 CFR 211.22(a)Lack of quality control unit