Dr Reddy's Labs Receives EIR from USFDA for Visakhapatnam Units

Dr Reddy's Laboratories Ltd announced it has received an Establishment Inspection Report (EIR) from the USFDA for its formulations manufacturing units in Visakhapatnam, marking the facilities as Voluntary Action Indicated (VAI). The USFDA inspection concluded with two observations, which Dr Reddy's committed to addressing within the prescribed timeline.

Dr Reddy's Laboratories Ltd has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its formulations manufacturing units located in Duvvada, Visakhapatnam. The US health regulator has classified these facilities as Voluntary Action Indicated (VAI).

The conclusion of the inspection, as mentioned by Dr Reddy's Laboratories in a regulatory filing, signifies that no critical violations were found that would warrant further regulatory action. Earlier, the USFDA had issued a Form 483 to the company following an inspection conducted from May 8 to May 17, 2024, highlighting two observations that needed to be addressed.

In May, Dr Reddy's had assured stakeholders that it would resolve the issues within the stipulated timeline. The Form 483 serves as a formal record when an investigator spots conditions during the inspection that may breach the Food, Drug, and Cosmetic (FD&C) Act.

(With inputs from agencies.)