Aurobindo Pharma Gets 14 Observations From The USFDA For Hyderabad Plant

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.

“At the end of the inspection, we have been issued a Form 483 with 14 observations,” it added.

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.