Dr Reddy’s Laboratories on Friday said the US health regulator has issued a Form 483 with two observations after inspecting one of its formulation plants in Hyderabad. In a regulatory filing, the drug major said the US Food and Drug Administration (USFDA) completed audit of its formulations manufacturing plant - 3 at Bachupally, Hyderabad on Friday.
“We have been issued a Form 483 with two observations. We will address them comprehensively within the stipulated timeline,” it added.
As per the USFDA, Form 483 is issued to firm management at the conclusion of an inspection when investigators have observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts.
Dr Reddy’s shares on Friday ended 4.66 per cent up at Rs 2,925.80 apiece on the BSE.