DRL gets 7 observations after USFDA inspection of Hyderabad biologics plant

USFDA completed a pre-license inspection of the Hyderabad facility and issued a Form 483 with seven observations, which the company said it will address within the stipulated timeline

Drugmaker Dr Reddy's Laboratories (DRL) on Thursday said the US Food and Drug Administration (USFDA) has completed a pre-license inspection (PLI) of its biologics manufacturing facility at Bachupally, Hyderabad, and issued a Form 483 with seven observations.

 

The inspection was conducted between June 16 and June 25, 2026, the company said in a regulatory filing to the stock exchanges.

 

Dr Reddy's said it would address all seven observations within the stipulated timeline.

 

A Form 483 is issued by the USFDA when investigators identify conditions that may constitute deviations from current Good Manufacturing Practices (cGMP) or other regulatory requirements. The observations are preliminary and do not represent the agency's final determination.

 

The inspection is part of the regulatory review process for manufacturing facilities seeking approval to produce biologic medicines for the US market.