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 3009876430.
Observations8
Issue DateNovember 21, 2025
StatusWarning Letter Issued
Establishment TypeDrug Manufacturer
Related Inspections6
Establishment Details
Firm
Shilpa Medicare Limited
Location
Jadcherla, -, India
FEI Number
3009876430
Establishment Type
Drug Manufacturer
Product Type
Drugs
Issue Date
November 21, 2025
Country
India
Inspection History, 2015 to 2020
NAI2
VAI3
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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