USFDA Raises Concerns: Dr Reddy's Receives Form 483 for Srikakulam Plant

Dr Reddy's Laboratories received a Form 483 with seven observations from the USFDA for its Srikakulam-based plant in Andhra Pradesh. The inspection, conducted from July 10 to 18, 2025, highlighted potential violations of the FD&C Act. Dr Reddy's has committed to addressing the observations promptly.

Dr Reddy's Laboratories has encountered regulatory hurdles as the US Food and Drug Administration (USFDA) issued seven observations in a Form 483 for its formulations manufacturing facility in Srikakulam, Andhra Pradesh.

This development follows a Good Manufacturing Practice (GMP) and Pre-Approval Inspection (PAI) conducted by USFDA officials from July 10 to 18, 2025, according to the Hyderabad-based pharmaceutical giant's regulatory filing.

The observations indicate potential breaches of the Food, Drug, and Cosmetic Act and related Acts, which Dr Reddy's Laboratories is set to address within the designated timeline provided by USFDA.

(With inputs from agencies.)