Dr Reddy’s Laboratories has received a Form 483 with seven observations from the US health regulator for its Srikakulam-based plant in Andhra Pradesh, according to a regulatory filing.
The US Food and Drug Administration (USFDA) conducted the GMP and a Pre-Approval Inspection (PAI) at the formulations manufacturing facility from July 10 to 18, 2025, the Hyderabad-based drug major said in the filing.
“We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline,” it added.
As per the USFDA, Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food, Drug and Cosmetic (FD&C) Act and related Acts.
