Aurobindo Pharma has reported that its formulation manufacturing facility in Telangana received 11 procedural observations from the United States Food and Drug Administration (FDA) after a routine inspection. The audit was carried out at Unit-III of Eugia Pharma Specialities Ltd., a wholly owned subsidiary of Aurobindo Pharma, between January 27 and February 6, 2026.

According to the company’s regulatory filing, the observations relate to procedural matters identified during the inspection, and Aurobindo has said it will respond formally to the regulator within the stipulated timeframe. The company emphasised that the findings are not expected to have any financial or operational impact on its business or on supplies from the facility.

The manufacturing unit in Pashamylaram, in Sangareddy District, Telangana, is part of Aurobindo’s broader production network that supplies pharmaceutical products to global markets, including the United States. Aurobindo said it remains committed to maintaining high standards of quality and regulatory compliance across all its manufacturing sites.

A Form FDA 483 is typically issued at the end of an inspection when the regulator identifies conditions that may suggest potential violations of the Federal Food, Drug, and Cosmetic Act and related regulations. While the reported observations are procedural in nature, the company will implement corrective and preventive actions as required to address the regulator’s expectations.

The inspection outcome highlights ongoing regulatory oversight of drug manufacturing facilities exporting to the United States, where adherence to quality and compliance standards is critical for continued market access.