USFDA classifies Aurobindo Pharma's US facility as 'official action indicated'

New Delhi: Drug firm Aurobindo Pharma on Wednesday said the American health regulator has classified its US manufacturing facility as "official action indicated".

The facility belongs to Lannett Company LLC, a wholly owned step-down subsidiary of Aurobindo Pharma.

The US Food and Drug Administration (USFDA) conducted the inspection at the Seymour facility from August 17-21, 2026, Aurobindo Pharma said in a regulatory filing.


After the completion of the inspection, the USFDA issued four observations, to which the company responded within the stipulated time.

"The USFDA has now determined that the inspection classification of this facility is 'official action indicated' (OAI)," the drug maker said.

In pharmaceutical regulatory terms, an OAI classification means regulatory or administrative actions are recommended by the USFDA as significant objectionable conditions or violations were observed during the inspection.

Aurobindo Pharma, however, stated that "there is no impact on the company's financials or operations due to the said action".

The company added that it remains committed to maintaining robust quality and compliance standards across its manufacturing facilities and will keep stock exchanges informed of any further developments.