FDA Flags Aurobindo Pharma Unit In Rajasthan

NEW DELHI-Aurobindo Pharma on March 17 said that the US Food and Drug Administration (USFDA) has classified one of its subsidiary units as “Official Action Indicated” following an inspection conducted last year.

In a regulatory filing, the company said that the USFDA inspected Unit-II of Eugia Pharma Specialties Limited, its wholly-owned subsidiary, located in Bhiwadi, Rajasthan, between November 3 and 14, 2025.

At the end of the inspection, the regulator had issued a Form 483 with nine observations.

The OAI classification means that the regulator believes certain issues found during the inspection may require regulatory action.

However, the company clarified that it does not expect any immediate impact on its business operations due to this development.

“At this point in time, the Company doesn’t foresee any impact on the business. The Company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe,” Aurobindo Pharma stated. (IANS)