The United States Food & Drug Administration (USFDA) completed a product specific Pre-Approval Inspection (PAI) at our biologics manufacturing facility in Bachupally, Hyderabad.

“We have been issued a Form 483 with nine observations, which we will address within the stipulated timeline,” Dr Reddy's Labs said in a regulatory filing.

The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally.

The inspection was conducted from October 4, 2023 to October 12, 2023.