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 3007373532.
Observations9
Issue DateFebruary 10, 2026
StatusWarning Letter Issued
Establishment TypeFinished Drug Product Manufacturer
Related Inspections7
Establishment Details
Firm
Aurobindo Pharma Limited, Unit VII
Location
Jedcherla Mandal, Mahabubnagar, -, India
FEI Number
3007373532
Establishment Type
Finished Drug Product Manufacturer
Product Type
Drugs
Issue Date
February 10, 2026
Country
India
Inspection History, 2009 to 2022
NAI4
VAI2
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.