FDA Inspection 1112104 — Dabur India Limited

Dabur India Limited — FEI 3001413302

The FDA completed an inspection of Dabur India Limited on December 6, 2019 in Dadra And Nagar Haveli. 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, 2019
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Dadra And Nagar Haveli (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