USFDA issues Form 483 with 8 observations to Aurobindo's Telangana unit

Aurobindo Pharma on Friday said the US health regulator has issued a Form 483 with eight observations after inspecting its Telangana-based manufacturing plant.

The US Food and Drug Administration (US FDA) inspected the company's Unit-XII, which includes both oral solids and injectable manufacturing units, situated at Bachupally, Telangana from August 25 to September 5, the Hyderabad-based drug firm said in a regulatory filing.

At the end of the current inspection, a 'Form 483' was issued with a total of eight observations for both (oral solids & injectable, it added.


"All observations are procedural in nature. We will respond to the US FDA within the stipulated timelines," the company said.

As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.