FDA Inspection 826835 — Sanford Broadway Clinic Laboratory

Sanford Broadway Clinic Laboratory — FEI 3006986912

The FDA completed an inspection of Sanford Broadway Clinic Laboratory on April 11, 2013 in Fargo, ND. 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 11, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Fargo, ND (United States)

Citations

IDCFRDescription
16721 CFR 606.170(b)Adverse reaction - fatality