Dr Reddy’s Hyderabad facility receives FDA 483

The US FDA has issued a Form 483 with nine observations for Dr. Reddy’s Laboratories’ biologics facility in Bachupally, India. 

The product-specific pre-approval inspection (PAI) was initiated on October 4, 2023, and concluded on October 12, 2023, by a US Food and Drug Administration (FDA) inspector. 

In a filing with the Bombay Stock Exchange, Dr Reddy’s wrote, “We have been issued a Form 483 with nine observations which we will address during stipulated timeline.”

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Following the issuing of a Form 483, the company has 15 days to submit its response to the FDA outlining the steps it will take to address the Agency’s observations.  

According to its website, the Bachupally, Hyderabad unit is a WHO approved cGMP (Current Good Manufacturing Practice) biologics manufacturing facility. The facility includes on-site drug substance (DS) and drug product (DP) manufacturing. 

This is the latest regulatory tick-off for the Bachupally site. In 2019, the site received a form 483 with 11 violations regarding a formulation facility on the campus. Moreover, in 2017 German authorities cancelled the firm’s manufacturing certificate after visiting a formulation unit at Bachupally citing defects in quality control and sanitation. 

Beyond the Bachupally plant, Dr Reddy’s biologics network includes facilities in Basel, Switzerland, and New Jersey, US. In total, the firm boasts a manufacturing capacity of more than 14,000 liters and multiple reactors of 1,000 liters 

Dr Reddy’s did not provide more information when contacted by this publication.