1197718

SSM-SLUH, Inc. — FEI 1972831

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 17, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Saint Louis, MO (United States)

Citations

IDCFRDescription
430421 CFR 211.68(b)Written record not kept of program and validation data
440221 CFR 211.192Written record of investigation incomplete
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs