FDA Inspection 1182340 — Taejoon Pharmaceutical Co., Ltd.

Taejoon Pharmaceutical Co., Ltd. — FEI 3008029795

The FDA completed an inspection of Taejoon Pharmaceutical Co., Ltd. on October 18, 2022 in Yongin. 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: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 18, 2022
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Yongin (Korea (the Republic of))

Citations

IDCFRDescription
360321 CFR 211.160(b)Scientifically sound laboratory controls