FDA Inspection 998105 — Baxalta US Incorporated

Baxalta US Incorporated — FEI 2011021

The FDA completed an inspection of Baxalta US Incorporated on December 13, 2016 in Los Angeles, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 13, 2016
Fiscal Year
2017
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Los Angeles, CA (United States)