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1036549

Paradox Inc — FEI 1927976

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 27, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Saint Joseph, MO (United States)

Facility

Other inspections at this facility

  • 1252435 (VAI Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1148358 (VAI Wed Aug 04 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031191 (VAI Mon Nov 06 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 946214 (VAI Wed Sep 02 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 865872 (OAI Fri Feb 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
113321 CFR 211.25(a)GMP Training Frequency
180921 CFR 211.160(a)Following/documenting laboratory controls
261821 CFR 211.198(b)(1)Complaint Record required information
435321 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs