729730

CareFusion 213, LLC — FEI 3004932373

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 3, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
El Paso, TX (United States)

Citations

IDCFRDescription
185221 CFR 211.94(a)Reactive/Additive/Absorptive Containers/Closures
358321 CFR 211.110(a)Written in-process control procedures
437521 CFR 211.188(b)(5)In-process and laboratory control results
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications