FDA Inspection 1325640 — SK Biotek Co., Ltd. (Sejong Plant)

SK Biotek Co., Ltd. (Sejong Plant) — FEI 3014286622

The FDA completed an inspection of SK Biotek Co., Ltd. (Sejong Plant) on Jun 10, 2026 in Sejong. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jun 10, 2026
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Sejong (Korea (the Republic of))