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 3003821988.
Observations4
Issue DateFebruary 21, 2025
Status1 Related Warning Letter
Establishment TypeSterile Drug Manufacturer
Related Inspections10
Establishment Details
Firm
Somerset Therapeutics Private Limited
Location
Bengaluru, -, India
FEI Number
3003821988
Establishment Type
Sterile Drug Manufacturer
Product Type
Drugs
Issue Date
February 21, 2025
Country
India
Inspection History, 2009 to 2025
NAI1
VAI5
OAI4
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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