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 3015392060.
Observations6
Issue DateSeptember 16, 2025
Status2 Related Warning Letters
Establishment TypeSterile Drug Manufacturer
Related Inspections2
Establishment Details
Firm
Lupin Limited
Location
Nagpur, India
FEI Number
3015392060
Establishment Type
Sterile Drug Manufacturer
Product Type
Devices
Issue Date
September 16, 2025
Country
India
Inspection History, 2024 to 2025
NAI1
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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