U.S. FDA issues five observations to Aurobindo Pharma arm’s API plant

An active pharmaceutical ingredients manufacturing facility of Aurobindo Pharma subsidiary Apitoria Pharma near Hyderabad has been issued five observations by the U.S. Food and Drug Administration.

The U.S. FDA has inspected Unit-I, an API manufacturing facility, of Apitoria Pharma, located in Sangareddy district from August 21-29. At the end of the inspection, a Form 483 was issued with 5 observations which are procedural in nature and no data integrity issues were reported. 

“We will respond to the U.S. FDA within the stipulated timelines,” Aurobindo Pharma said in a filing on Friday.