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.
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.