FDA Inspection 1010187 — Lotte Biologics USA, LLC

Lotte Biologics USA, LLC — FEI 1317757

The FDA completed an inspection of Lotte Biologics USA, LLC on April 28, 2017 in East Syracuse, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 28, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
East Syracuse, NY (United States)