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1288506

CareFusion 213, LLC — FEI 3004932373

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 24, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
El Paso, TX (United States)

Facility

Other inspections at this facility

  • 1219336 (VAI Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 997744 (NAI Thu Dec 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 871049 (NAI Tue Mar 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 818062 (VAI Fri Feb 08 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 729730 (OAI Fri Jun 03 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
127021 CFR 211.68(b)input/output verification
180921 CFR 211.160(a)Following/documenting laboratory controls
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
360321 CFR 211.160(b)Scientifically sound laboratory controls