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 3003560263.
Observations6
Issue DateFebruary 07, 2025
Status1 Related Warning Letter
Establishment TypeAPI and Intermediate Manufacturer
Related Inspections4
Establishment Details
Firm
Hikal Limited
Location
Jigani, -, India
FEI Number
3003560263
Establishment Type
API and Intermediate Manufacturer
Product Type
Drugs
Issue Date
February 07, 2025
Country
India
Inspection History, 2011 to 2025
NAI2
VAI1
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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