Shares of Dr Reddy’s Laboratories Ltd dipped after the company announced that the US Food and Drug Administration (USFDA) issued a Form 483 with seven observations for its active pharmaceutical ingredient (API) manufacturing facility in Bollaram, Hyderabad.
The inspection, conducted from November 13 to 19, 2024, concluded with the issuance of the Form 483, which highlights potential violations of the Food Drug and Cosmetic (FD&C) Act. Dr Reddy’s Laboratories stated in a regulatory filing, “We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline.”
The company assured investors of its commitment to resolving the issues raised during the inspection. Form 483 is a standard document issued at the end of an inspection, listing areas of non-compliance that may need corrective actions.
