Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3004819820.
Observations7
Issue DateNovember 21, 2025
StatusWarning Letter Issued
Establishment TypeDrug Manufacturer
Related Inspections9
Establishment Details
Firm
Lupin Limited
Location
Verna, -, India
FEI Number
3004819820
Establishment Type
Drug Manufacturer
Product Type
Drugs
Issue Date
November 21, 2025
Country
India
Inspection History, 2009 to 2025
NAI2
VAI6
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.