863164

Baxter Healthcare Corporation — FEI 1019003

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 23, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Cleveland, MS (United States)

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
109821 CFR 211.22(c)Approve or reject procedures or specs
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
358521 CFR 211.110(a)Control procedures to monitor and validate performance