FDA Inspection 1195374 — Huons Co., Ltd.

Huons Co., Ltd. — FEI 3007163376

The FDA completed an inspection of Huons Co., Ltd. on January 19, 2023 in Jecheon. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 19, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Jecheon (Korea (the Republic of))

Citations

IDCFRDescription
237121 CFR 820.30(a)Design control - no procedures