The audit of DRL’s Srikakulum Plant (SEZ) Unit I, Andhra Pradesh by US FDA was recently completed
Dr Reddy’s Laboratrories (DRL) said the US health regulator has issued four observations after inspecting its formulations unit in Andhra Pradesh.
“The audit of our formulations Srikakulum Plant (SEZ) Unit I, Andhra Pradesh by the US Food and Drug Administration (USFDA), has been completed today. We have been issued a Form 483 with four observations, which we are addressing,” the Hyderabad-based company said in a regulatory filing.
As per the US FDA, a Form 483 is issued to a firm’s management at the conclusion of an inspection when investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. It notifies the company’s management of objectionable conditions.