US. FDA issues Form 483 with four observations to Aurobindo Pharma

The U.S. Food and Drug Administration has issued a Form 483 with four observations to Aurobindo Pharma after inspecting the company’s (Unit XIV) active pharmaceutical ingredient manufacturing facility in Andhra Pradesh.

The API non-antibiotic manufacturing facility in Paravada Industrial Area, Anakapalli district, was inspected from May 15-19. “We have been issued a Form 483 with four observations [which] are procedural in nature,” Aurobindo said. The company said it will respond within the stipulated timelines and work closely with regulator to close the observations at the earliest.

On Friday, Aurobindo shares closed 1.64% lower at ₹589.45 each on the BSE.