FDA Inspection 1257160 — Yash Pharmaceuticals

Yash Pharmaceuticals — FEI 3012020703

The FDA completed an inspection of Yash Pharmaceuticals on December 6, 2024 in Roorkee. 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: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 6, 2024
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Roorkee (India)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
126321 CFR 211.68(b)Computer control of master formula records