Source: FDA record for this establishment. FDA publishes inspections or enforcement actions for this establishment, listed further down this page, but we have not matched this particular Form 483 to a document or an inspection date FDA has released. It stays out of the default view for that reason. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3009093782.
Observations6
Issue DateSeptember 26, 2025
StatusWarning Letter Issued
Related Inspections5
Establishment Details
Firm
Hetero Labs Limited, Unit-IX
Location
India
FEI Number
3009093782
Product Type
Drugs
Issue Date
September 26, 2025
Country
India
Inspection History, 2011 to 2022
NAI1
VAI3
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.