Aurobindo Pharma subsidiary clears FDA warning letter

Aurobindo Pharma announced today that the US Food and Drug Administration (US FDA) has concluded its inspection of Unit-I of Apitoria Pharma Private Limited, classifying the facility as "Voluntary Action Indicated" (VAI). This follows a for-cause inspection conducted from August 21 to August 29, 2025, which initially resulted in Form 483 with five observations.

The US FDA has completed its evaluation of corrective actions submitted in response to a Warning Letter dated January 14, 2022, as well as addressing the subsequent five observations from the recent inspection. The FDA determined that all issues have been adequately addressed, resulting in the closure of the Warning Letter and the issuance of an Establishment Inspection Report (EIR) with a VAI classification.

This resolution signifies the closure of the inspection and is expected to have a positive impact on the operations of Apitoria Pharma's Unit-I, an API manufacturing facility located in Telangana, India.