Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3003821360.
Observations4
Issue DateMay 31, 2025
StatusWarning Letter Issued
Related Inspections8
Establishment Details
Firm
Alembic Pharmaceuticals Limited (Units I and II)
Location
Panchmahal, India
FEI Number
3003821360
Product Type
Drugs
Issue Date
May 31, 2025
Country
India
Inspection History, 2011 to 2025
NAI4
VAI4
NAI means No Action Indicated. VAI means Voluntary Action Indicated.