The company has been issued a Form 483
Dr Reddy’s Laboratories said the US health regulator has issued five observations after audit of a company’s plant in Hyderabad.
“The audit of our active pharmaceutical ingredient (API) manufacturing plant 2 at Bollaram, Hyderabad by the United States Food and Drug Administration (US FDA), has been completed today,” Dr Reddy’s said in a filing to BSE.
The company has been issued a Form 483 with 5 observations, it added.
“We will address them comprehensively within the stipulated timeline,” Dr Reddy’s said. It however did not provide any details about the observations made by the regulator.
As per the US FDA, Form 483 notifies the company’s management of objectionable conditions.
It is issued to the firm’s management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.