FDA Inspection 1026384 — Unigen Inc.

Unigen Inc. — FEI 3011033616

The FDA completed an inspection of Unigen Inc. on June 15, 2017 in Ibi-Gun. 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
June 15, 2017
Fiscal Year
2017
Product Type
Biologics
Project Area
Vaccines and Allergenic Products
Location
Ibi-Gun (Japan)