746444

South Bend Medical Foundation, Inc. — FEI 1870308

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 22, 2011
Fiscal Year
2011
Product Type
Biologics
Project Area
Blood and Blood Products
Location
South Bend, IN (United States)

Citations

IDCFRDescription
1220221 CFR 606.170(a)Adverse Reaction - Investigations
1503021 CFR 606.60(b)Equipment calibration frequency
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs