The U.S. drug regulator has flagged 10 quality and procedural lapses at Aurobindo Pharma Ltd.’s active pharmaceutical ingredient intermediate manufacturing facility in Sangareddy District of Telangana.
“U.S. Food and Drug Administration inspected the Company’s Unit-IX, an intermediate facility situated at Gundlamachnoor Village, Sangareddy district, Telangana, from Nov. 10 to Nov. 18, 2022,” the company said, in a Nov. 19 exchange filing.
“At the end of the inspection, the company has been issued a ‘Form 483’ with 10 observations.”
A Form 483 is issued when investigators have observed any condition that, in their judgment, may constitute a violation of the Federal Food, Drug and Cosmetic Act and related acts.
The unit was classified as ‘official action initiated’ on May 17, 2019, the company said in the filing. The U.S. FDA authorities reinspected the facility.
“In our view, these observations are procedural in nature and not related to data integrity,” it said.
The company said that it will respond to the U.S. FDA, within the stipulated timeline and shall work closely with the agency to address the observations at the earliest.
BQ Prime has obtained a copy of the observations from the U.S. FDA.
Aurobindo Pharma has yet to respond to BQ Prime’s emailed queries on the implications of the observations, impact on existing revenue from the facility, steps being taken to address the issues, expected timelines for resolution, whether there are pending approvals from the facility and would they get impacted.
Shares of Aurobindo Pharma were trading 0.27% higher, as of 3:05 p.m., compared with a 0.73% decline in the Sensex.