FDA Inspection 1256639 — Hugel Inc.

Hugel Inc. — FEI 3012163998

The FDA completed an inspection of Hugel Inc. on October 19, 2023 in Chuncheon. 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
October 19, 2023
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chuncheon (Korea (the Republic of))

Additional Details

Mutual Recognition Agreement (MRA)