India Pharma Outlook Team | Monday, 01 September 2025
Aurobindo Pharma announced today that its wholly owned subsidiary Apitoria Pharma received a Form 483 with five observations from the US Food and Drug Administration (FDA).
The form was received after the agency performed an inspection of its API manufacturing site located in Telangana.
The inspection at Apitoria Pharma’s site located in Hatnoor Mandal occurred from August 21 to 29, 2025.
Aurobindo Pharma stated in its disclosure on stock exchange that the FDA’s five observations were procedural in nature, and there were no data integrity findings, which provides confidence for industry participants and investors.
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In its statement, Aurobindo Pharma stressed that it would send a complete response to the FDA within the established timelines. Aurobindo Pharma also clarified that the observations have no impact on financial performance or ongoing operations, implying the observations were not serious.
In an observation under Form 483 is issued when FDA investigators observe possible situations that could violate the Food, Drug, and Cosmetic Act or associated regulations.
Although they are not near violations that would take immediate enforcement action, they are early warning indicators that allow the company the opportunity to correct the compliance gap before a potentially more serious regulatory action occurs.
Given its proactive approach together with its timing and assurance of timely corrective actions, Aurobindo Pharma has attempted to re-establish confidence in its regulatory compliance system while remaining focused on maintaining uninterrupted operations at its Apitoria Pharma API facility.
