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Dr. Reddy’s gets seven USFDA observations after Srikakulam plant inspectionDr. Reddy’s shares ended 0.4% lower today at a price of ₹1,258.10 on the BSE.By Poonam Behura  July 18, 2025, 6:59:44 PM IST (Published)1 Min ReadThe US Food and Drug Administration (USFDA) has issued a Form 483 with seven observations to Dr. Reddy’s Laboratories Ltd after completing a Good Manufacturing Practices (GMP) and Pre-Approval Inspection (PAI) at the company’s formulations facility FTO 11 in Srikakulam, Andhra Pradesh.

The inspection was conducted over eight days, from July 10 to July 18, 2025, the drugmaker said in a regulatory filing on Friday.

The company added that it would address the observations within the stipulated timeline and termed the disclosure as part of its obligations under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

FTO 11 is one of Dr. Reddy’s key manufacturing sites for formulations intended for global markets.

The company did not specify the nature of the observations in the Form 483. The issuance of a Form 483 indicates that the USFDA inspectors observed conditions that may violate the US Food Drug and Cosmetic Act and requires a response within a defined period, typically 15 working days.

Dr. Reddy’s shares ended 0.4% lower today at a price of ₹1,258.10 on the BSE.

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