The U.S. Food and Drug Administration (FDA) has designated the formulation manufacturing facility of Aurobindo Pharma's subsidiary, Eugia Pharma Specialities, located in Kolthur village, Ranga Reddy district, India, with an Official Action Indicated (OAI) classification. This classification was issued following an inspection that took place from February 16 to 27, 2026, during which the FDA noted four observations that prompted this regulatory action. The OAI classification signifies that the FDA recommends regulatory and/or administrative actions due to the issues identified during the inspection. In response to the classification, Aurobindo Pharma stated its commitment to upholding the highest quality manufacturing standards across all its global facilities. The FDA utilizes three classifications following inspections: No Action Indicated (NAI), which indicates no objectionable conditions were found; Voluntary Action Indicated (VAI), which suggests that while issues were noted, no immediate regulatory actions are required; and Official Action Indicated (OAI), which denotes that further actions are necessary.