Express Pharma

DRL gets eight observations from US FDA

33

The audit of DRL’s formulations manufacturing facility at Duvvada, Visakhapatnam was completed today

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.

Dr Reddy’s Laboratories said US health regulator has issued eight observations after inspecting its formulations plant at Duvvada, Visakhapatnam. “The audit of our formulations manufacturing facility at Duvvada, Visakhapatnam, by the  US Food and Drug Administration(USFDA), has been completed today. We have been issued a Form 483 with eight observations, which we are addressing,” the company said in a regulatory filing.

As per the USFDA, 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.

 

 

Comments are closed.