U.S. FDA Flags Four Observations At Aurobindo Pharma's Andhra Facility
Aurobindo Pharma says it will work closely with the FDA to close the observations at the earliest.
The U.S. Food and Drug Administration has flagged four observations at Aurobindo Pharma Ltd.'s facility in Andhra Pradesh's Anakapalli district.
The FDA inspected the Unit XIV—an active pharmaceutical ingredient non-antibiotic manufacturing facility at the Parawada Industrial Area—from May 15–19, the company said in an exchange filing on Friday. "At the end of the inspection, we have been issued a Form 483 with four observations."
A Form 483 is issued when investigators have observed any condition that, in their judgement, may constitute a violation of the Food, Drug, and Cosmetic Act, and related acts.
The company said the observations were procedural in nature. "We will respond to the U.S. FDA within the stipulated timelines and work closely with the U.S. FDA to close the observations at the earliest."
Shares of the company closed 1.64% lower on Friday, as compared with a 0.48% rise in the benchmark S&P BSE Sensex.