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 3013712903.
Observations4
Issue DateSeptember 05, 2025
StatusWarning Letter Issued
Establishment TypeSterile Drug Manufacturer
Related Inspections2
Establishment Details
Firm
Zydus Lifesciences Limited
Location
Jarod, -, India
FEI Number
3013712903
Establishment Type
Sterile Drug Manufacturer
Product Type
Drugs
Issue Date
September 05, 2025
Country
India
Inspection History, 2022 to 2024
VAI1
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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