U.S. FDA Flags One Lapse At Aurobindo Pharma's Andhra Pradesh Facility

The U.S. drug regulator has flagged one lapse at Aurobindo Pharma Ltd.'s fully owned subsidiary's formulation manufacturing facility in Andhra Pradesh.

"The United States Food and Drug Administration inspected Unit IV, a formulation manufacturing facility, of APL Healthcare Ltd., a wholly owned subsidiary of the company, situated at Menakuru Village, Naidupeta Mandal, Tirupati District, Andhra Pradesh, from Sept. 13 to Sept. 19," according to an exchange filing on Sept. 20.

At the end of the inspection, a ‘Form 483' was issued with one observation that was procedural in nature, the company had disclosed.

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.

"We will respond to the U.S.FDA within the stipulated timelines and work closely with the U.S.FDA to close the observation at the earliest," the company said.

BQ Prime has obtained a copy of the observation from the administrator.

The administrator said that the company has failed to thoroughly review any unexplained discrepancy or failure of any batch or its components to meet any of the specifications.

This specifically pertained to failure to ensure that documented conclusions resulting from laboratory and production non-conformance investigations are scientifically justified and supported. These conclusions are used to make decisions with regards to the manufacturing and release of drug products.

Three instances were specifically noted: one relating to laboratory investigation, the second relating to production investigation, and the third relating to failure in initiating investigations and taking corrective and preventive action to minimise the future reoccurrence of non-conformances in the laboratory.

Emailed queries regarding the impact of the observation on revenues and the time period of resolution sent to the company remain unanswered at the time of publication.

Shares of Aurobindo Pharma were trading 0.92% lower at Rs 902.10 apiece at 1:44 pm, as compared with a 0.97% rise in the benchmark Sensex on Tuesday.