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

Shreeyashi Ojha, Reporter

October 16, 2023

1 Min Read
Dr Reddy’s Hyderabad facility receives FDA 483
DepositPhotos/paulrommer

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.”

hyderabad-paulrommer-300x197.jpg

DepositPhotos/paulrommer

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. 

About the Author(s)

Shreeyashi Ojha

Reporter, BioProcess Insider

Journalist covering the manufacturing and processing sectors for biopharmaceuticals globally.  

Originally from India, I am a Londoner at heart. I have recently graduated from Goldsmiths, University of London.  

Feel free to reach out to me at: [email protected].

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