Dr. Reddy's receives 7 observations from USFDA after inspection at Srikakulam plant
Dr. Reddy's Laboratories Ltd. announced on July 18 that the United States Food & Drug Administration (USFDA) has completed a Good Manufacturing Practice (GMP) and Pre-Approval Inspection (PAI) at its formulations manufacturing facility FTO 11, located in Srikakulam, Andhra Pradesh.
According to the company's filing with stock exchanges, the inspection was conducted over eight days, from July 10 to July 18, 2025. At the conclusion of the inspection, the USFDA issued a Form 483 with seven observations.
Dr. Reddy's stated that it would address the observations within the stipulated timeline, as per regulatory requirements.
The company said the disclosure was made under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, and is meant for public record and investor information.
The Hyderabad-headquartered pharmaceutical major operates several manufacturing facilities in India and abroad, and this development comes as part of its routine regulatory inspections for ongoing compliance and product approvals.
Disclaimer: This information is based solely on the company's official disclosure dated July 18, 2025. Business Upturn or the author is not liable for any actions taken based on this information. Investors are advised to independently verify and consult financial advisors before making investment decisions.
Ahmedabad Plane Crash
Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
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