Dr Reddy's gets 7 USFDA observations after Srikakulam plant inspection

Hyderabad-based pharmaceutical major Dr Reddy’s Laboratories (DRL) has received a Form 483 with seven observations from the United States Food and Drug Administration (USFDA) in a recent inspection at its formulations manufacturing plant in Srikakulam, Andhra Pradesh, according to the exchange filing.

 

The regulatory inspection, which covered both Good Manufacturing Practices (GMP) and a Pre-Approval Inspection (PAI), was conducted from July 10 to July 15. 

 

The USFDA concluded the inspection of its FTO 11 facilities, the company stated in the filing.

 

A Form 483 is issued by the US health regulator when inspectors identify conditions that may violate the Food, Drug, and Cosmetic (FD&C) Act or relevant guidelines.

 

“We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline,” it added.

 

Dr Reddy's Srikakulam facility, designated as FTO 11, plays an important role in the company’s global supply chain, particularly for formulations intended for the US market. 

 

Dr Reddy’s Laboratories reported a 22 per cent year-on-year rise in consolidated net profit for the fourth quarter of financial year 2025, reaching ₹1,593.9 crore. The company has also announced a final dividend of ₹8 per equity share for FY 2024-25.

 

The company’s first-quarter results for FY26 are scheduled to be released on July 23.