Aurobindo's oral solid formulations unit under USFDA scrutiny

The US Food and Drug Administration (US FDA) has escalated the audit observations issued for Unit 7 of Aurobindo Pharma Limited in October, 2019 to the Official Action Indicated (OAI) level in a latest communication to the company.

The latest classification of the audit evaluation indicates the regulatory and/or administrative actions will be recommended against the unit by the US drug regulator based on the objectionable conditions found during the inspection,

Aurobindo's Unit 7 oral solids formulations manufacturing facility located at Polepally in Telangana was issued Form 483 with 7 observations after a CGMP (current good manufacturing practices) inspection was conducted from September 19-27, 2019. Though the company maintained that it was confident of addressing these issues within the stipulated timeline, the OAI classification signals that the issues flagged during the previous inspections remain unresolved.

The company in a filing on Thursday said the OAI classification will not have any material impact on the existing revenues or the supplies to its US business at this juncture. "The company will work closely with the regulator to comprehensively address the issues,"it has added.

The year 2019 was a challenging year for Aurobindo on regulatory compliance front as half a dozen of its manufacturing facilities fell short of the aspects involving compliance parameters or the manufacturing practices prescribed by the US drug regulator. In June, 2019 the company had received a warning letter from the US FDA for Unit 11 active pharmaceutical ingredients (API) manufacturing facility in Srikakulam of Andhra Pradesh for CGMP issues among other things.