The US Food and Drug Administration (FDA) has classified Unit-I of Aurobindo Pharma’s wholly owned subsidiary, Eugia Pharma Specialities, as ‘Official Action Indicated’ (OAI) following an inspection of its formulation manufacturing facility in Telangana’s Ranga Reddy district, ET reported.
The inspection, conducted between 16 February and 27 February 2026, resulted in four observations related to compliance gaps. The company confirmed receiving the OAI notice on May 23, 2026. An OAI status signals significant compliance concerns and may delay approvals for new products from the site until corrective actions are implemented.
However, Aurobindo Pharma stated that the development will not have an immediate impact on its operations or financial performance, while reaffirming its commitment to restoring full regulatory compliance, media reports said.
