DRL gets FDA inspection report for Vizag units

Hyderabad: Dr Reddy’s Laboratories Ltd on Monday said it has received an Establishment Inspection Report (EIR) from the US health regulator for its formulations manufacturing units at Duvvada in Visakhapatnam, classifying the facilities to voluntary action indicated.

The USFDA has classified the company’s formulations manufacturing facilities (FTO-7 & FTO-9) in Duvvada, as Voluntary Action Indicated (VAI) and concluded that the inspection is “closed”, Dr Reddy’s Laboratories Ltd said in a regulatory filing. Earlier, the USFDA had issued a Form 483 with two observations to the two units following inspection which was conducted from May 8 to May 17, 2024. In May, Dr Reddy’s had stated that it would address the issue within the stipulated timeline.

As 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.