FDA Inspection 1060004 — Simtra US LLC

Simtra US LLC — FEI 1000115571

The FDA completed an inspection of Simtra US LLC on May 23, 2018 in Bloomington, IN. 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
May 23, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Bloomington, IN (United States)