Aurobindo gets 8 FDA observations for 2 plants

Hyderabad: Aurobindo Pharma on Wednesday said the US health regulator has issued four observations each for its two units in Hyderabad after inspecting the sites last month.

The USFDA inspected active pharmaceutical ingredients (API) manufacturing facility (Unit V) at Pashamylaram and API manufacturing facility (Unit VIII) at Gaddapotharam in Hyderabad between October 21 and October 28, the company said.

"At the end of the inspections, we have been issued a Form 483 with four observations for each facility. We believe that these observations are related to procedural improvements and none of the observations are related to data integrity," it added.

The company will be responding to the USFDA as per the prescribed timelines, the drug firm said. The inspection of formulation manufacturing facility (Unit IV) at Pashamylaram is underway, it added.

Shares of Aurobindo Pharma tumbled 5 per cent on Wednesday after the company said the US health regulator has issued four observations each for its two units in Hyderabad after inspecting the sites last month.

On the BSE, the scrip declined 4.80 per cent to close at Rs 450.75. During the trade, the shares dropped 6.56 per cent to Rs 442.40. At the NSE, it fell 5 per cent to close at Rs 450.

Only last month, the USFDA has issued seven adverse observations to one of Aurobindo Pharma's Telangana units, criticising it for not keeping complete data records and for providing "potentially misleading" documents during inspection.

"Several lists of documents requested were either provided as incomplete, inaccurate, and/or explained with potentially misleading statements throughout the inspection," USFDA said in one of its observation in a Form 483 notification issued on September 27, for Aurobindo's Telangana unit.

Electronic audit trails revealed a number of interruptions during test runs between April 2018 and September 2019, but the company failed to review these trails and assess what caused the issues, the FDA said.

The US regulator added that the laboratory records at the facility did not have complete data of all tests necessary to ensure compliance with established standards.