FDA Inspection 1037339 — CSL Plasma Inc.

CSL Plasma Inc. — FEI 3009399851

The FDA completed an inspection of CSL Plasma Inc. on January 10, 2018 in Roseville, MI. 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
January 10, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Roseville, MI (United States)

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records