FDA Inspection 824259 — Cleveland Clinic Foundation

Cleveland Clinic Foundation — FEI 1000515577

The FDA completed an inspection of Cleveland Clinic Foundation on April 3, 2013 in Cleveland, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 3, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Cleveland, OH (United States)

Citations

IDCFRDescription
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs