FDA Inspection 1218362 — GEV Co.,Ltd.

GEV Co.,Ltd. — FEI 3010501626

The FDA completed an inspection of GEV Co.,Ltd. on September 6, 2023 in Eumseong. 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
September 6, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Eumseong (Korea (the Republic of))