Dr Reddys gets two USFDA observations for Vizag plants

Hyderabad: City-based Dr Reddy's Laboratories (Dr Reddys/ DRL) has reportedly fallen under the US health regulator's scanner. The company has been issued a couple of observations for two of its units in Andhra Pradesh.

The company stated that two of its formulations manufacturing units in Visakhapatnam namely Vizag SEZ Plant 1 and Vizag SEZ Plant 2 at Duvvada have been issued Form 483 with a couple of observations by the United States Food and Drug Administration (USFDA).

The audit of these two plants were completed on June 21, 2019.

Also Read: Dr Reddy's Lab shares gain 3 percent on zero USFDA observations for Srikakulam plant

According to the USFDA website, Form 483 is issued to a company at the conclusion of an inspection when investigators observe any conditions that, in their judgement, may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Responding the bourses regarding the observations, DRL stated, "We have been issued a Form 483 with two observations. We will address them comprehensively within the stipulated timeline."

As per a report by TOI, confirmation to this was given by Dr Reddy's in a BSE filing.

A few months back Medical Dialogues had reported that Dr Reddy's had received four observations from the USFDA for its Srikakulum Plant (SEZ) Unit I, Andhra Pradesh.

Also Read: Dr Reddy's gets four observations from USFDA for Andhra plant