The US Food and Drug Administration (FDA) has completed an inspection of Unit-I of Apitoria Pharma, a wholly owned subsidiary of Aurobindo Pharma, located in Borpatla, Sangareddy district, Telangana. The inspection was carried out from 21-29 August, 2025.

At the conclusion of the inspection, the regulatory agency issued a Form 483 with five observations. The company clarified that the observations were procedural in nature and did not involve any data integrity issues. Aurobindo said it will respond to the regulator within the stipulated timelines.

“The company is committed to maintain the highest quality manufacturing standards at all of its facilities across the globe,” Aurobindo Pharma said in a regulatory filing.

The drugmaker further noted that the US FDA’s action will have no impact on its financials or operations.