FDA Inspection 1019906 — Wakunaga Pharmaceutical Co.,ltd. Hiroshima

Wakunaga Pharmaceutical Co.,ltd. Hiroshima — FEI 3004303733

The FDA completed an inspection of Wakunaga Pharmaceutical Co.,ltd. Hiroshima on July 25, 2017 in Akitakata. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 25, 2017
Fiscal Year
2017
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Akitakata (Japan)

Citations

IDCFRDescription
1545021 CFR 111.15(f)(3)Plumbing - source of contamination
1556021 CFR 111.260(k)(2)Batch record - label