U.S. FDA issues 9 observations to Aurobindo Pharma unit

The U.S. Food and Drug Administration (U.S. FDA) has issued nine observations to the oral solid dosage manufacturing unit of generic drugmaker Aurobindo Pharma near Hyderabad.

The U.S. FDA inspected Aurobindo Pharma’s Unit-VII, an oral solid dosage manufacturing unit at SEZ (Pharma), TSIIC in Mahaboobnagar district, from January 28 to February 10. A Form 483 with nine observations was issued on conclusion of the inspection, Aurobindo Pharma said in a filing on Tuesday.

All observations are procedural in nature and the company will respond to the U.S. FDA within the stipulated timelines, it said. The development comes close on the heels of the formulation manufacturing facility of Aurobindo Pharma’s subsidiary Eugia Pharma Specialities in Hyderabad being issued 11 observations by the U.S. FDA.