707513

Methodist Medical Center of Illinois — FEI 1474020

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 17, 2011
Fiscal Year
2011
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Peoria, IL (United States)

Citations

IDCFRDescription
15021 CFR 606.151(e)Procedures to maintain records of emergency transfusions
15421 CFR 606.160(a)(1)Concurrent documentation
15521 CFR 606.160(b)Required records
15921 CFR 606.160(a)(1)Legibility and indelibility
16021 CFR 606.160(a)(1)Person performing, test results, interpretation
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
7821 CFR 606.100(c)Record review prior to release