FDA Inspection 1210103 — Lupin Limited

Lupin Limited — FEI 3009843207

The FDA completed an inspection of Lupin Limited on July 11, 2023 in Nagpur. 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
July 11, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Nagpur (India)

Citations

IDCFRDescription
240121 CFR 211.194(a)(4)Complete Test Data
440421 CFR 211.194(a)(1)Sample identification and other information