U.S. FDA issues seven observations to Dr. Reddy’s biologics manufacturing facility in Hyderabad

The U.S. Food and Drug Administration (USFDA) has issued seven observations to the biologics manufacturing facility of Dr. Reddy’s Laboratories in Bachupally, Hyderabad.

“A Form 483 with the seven observations was issued to the facility on completion of a pre-licence inspection (PLI) that was conducted between June 16 and June 25,” the generic drugmaker said. The observations will be addressed within the stipulated timeline, it said in a filing on Thursday (June 25, 2026).

The company cited two previous inspections of the facility in October 2023 and September 2025 when the U.S. FDA had issued a Form 483 each with nine and five observations respectively.