USFDA Inspection Results in Observations for Dr Reddy's API Plant

Dr Reddy's Laboratories' API plant in Telangana received two observations in a Form 483 during a recent inspection by the USFDA. The inspection occurred in May 2025, and the company intends to address the observations within the designated timeframe as per regulatory advice.

The US Food & Drug Administration (USFDA) has issued a Form 483 with two observations to Dr Reddy's Laboratories following a recent inspection of its active pharmaceutical ingredients (API) manufacturing facility in Telangana.

The Hyderabad-based pharmaceutical giant confirmed the inspection of its Miryalaguda-based API plant, known as CTO-5, was conducted by USFDA officials from May 19 to May 24, 2025. The findings were disclosed by the company in a late-evening filing on Saturday.

Form 483 is given when inspectors identify conditions potentially violating the Food Drug and Cosmetic Act. Dr Reddy's Laboratories stated its commitment to resolving the issues within the specified deadline.

(With inputs from agencies.)