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 a Reliable and Trusted News SourceAs 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.
