Aurobindo Pharma gets 14 USFDA observations for Pashamylaram facility

The US Food and Drug Administration (USFDA) inspected company's Unit IV, a general injectable formulation manufacturing facility situated at Pashamylaram, Hyderabad from November 4-13, Aurobindo Pharma said.

New Delhi: Aurobindo Pharma has received 14 observations from the US health regulator for its Hyderabad-based plant, according to a regulatory filing.

The US Food and Drug Administration (USFDA) inspected company's Unit IV, a general injectable formulation manufacturing facility situated at Pashamylaram, Hyderabad from November 4-13, Aurobindo Pharma said.

The company believes that none of the observations are related to data integrity issues and, it will respond to the USFDA within the stipulated timeline, Aurobindo Pharma said.

The observations issued by the USFDA notifies the company's management of objectionable conditions at the inspected facility.