Dr Reddy's Gets 2 USFDA Form 483 Observations at Andhra Pradesh Facility
Hyderabad: The United States Food and Drug Administration (USFDA) has issued a Form 483 with two observations following a Pre-Approval Inspection (PAI) at Dr Reddy's Laboratories' FTO-11 manufacturing facility in Pydibhimavaram, Andhra Pradesh.
The inspection was conducted from October 5 to October 7, 2026, according to the company’s regulatory filing. Following the inspection, the USFDA issued Form 483 containing two observations to the facility. Dr. Reddy’s Laboratories stated that it will address the observations within the stipulated timeline.
The inspection was carried out at the company’s FTO-11 manufacturing facility located in Pydibhimavaram, Andhra Pradesh. The facility forms part of Dr. Reddy’s manufacturing operations, which support the company’s pharmaceutical business and supply of medicines to regulated markets.
Dr. Reddy’s Laboratories is a Hyderabad-based global pharmaceutical company engaged in the development, manufacture and marketing of pharmaceutical products. The company operates across multiple therapeutic areas and has a presence in several international markets, including the United States, where products are subject to regulatory oversight by the USFDA.
A Pre-Approval Inspection is conducted by the USFDA as part of its regulatory assessment of manufacturing facilities associated with drug applications. During such inspections, regulators assess manufacturing operations and compliance with applicable requirements before approval of relevant products or applications.
The company has stated that the two observations received through Form 483 will be addressed within the timeline stipulated by the regulatory authority. The filing did not provide further details of the specific observations identified during the inspection.
Dr. Reddy’s Laboratories, headquartered at Banjara Hills, Hyderabad, was established in 1984 and is one of India’s major pharmaceutical companies.
