FDA Inspection 812116 — Rohto Pharmaceutical Co., Ltd. (Ueno Plant)

Rohto Pharmaceutical Co., Ltd. (Ueno Plant) — FEI 3003722237

The FDA completed an inspection of Rohto Pharmaceutical Co., Ltd. (Ueno Plant) on November 20, 2012 in Iga. 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
November 20, 2012
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Iga (Japan)