Dr Reddy's Laboratories Faces Form 483 from USFDA

Dr Reddy's Laboratories Ltd's API facility in Bollaram, Hyderabad, received a Form 483 with seven observations after a USFDA inspection. The inspection took place from November 13-19, 2024, and the company plans to address the issues identified within the given timeline.

Dr Reddy's Laboratories Ltd has been issued a Form 483 with seven observations by the US health regulator following an inspection of its pharmaceutical manufacturing facility in Bollaram, Hyderabad.

The US Food & Drug Administration (USFDA) carried out the Good Manufacturing Practice (GMP) inspection from November 13 to 19, 2024. At the conclusion of the inspection, the USFDA presented the Form 483 outlining potential violations.

The company has committed to resolving the issues within the stipulated timeline set by the regulatory body.

(With inputs from agencies.)