The U.S. Food and Drug Administration (FDA) has issued a Form 483 with five observations to Dr. Reddy’s Laboratories, a generic drugmaker, following a pre-approval inspection (PAI) of their biologics manufacturing facility in Hyderabad, India. The inspection took place from September 4-12, 2025, at the company’s facility in Bachupally, Hyderabad.
Dr. Reddy’s Laboratories has stated that they will address the observations within the stipulated timeline. This is not the first time the facility has received a Form 483 from the U.S. FDA. In October 2023, the same facility was issued a Form 483 with nine observations after a product-specific PAI. The company has noted that the latest development is related to the earlier inspection.
A Form 483 is a report detailing observations of objectionable conditions or practices during an FDA inspection. It is not a final judgment but rather an opportunity for the company to address the concerns raised by the FDA. Dr. Reddy’s Laboratories will need to respond to the observations and implement any necessary corrections to ensure compliance with FDA regulations.
The fact that the number of observations has decreased from nine to five since the last inspection in 2023 may indicate that the company has made progress in addressing the concerns raised by the FDA. However, the company will still need to take prompt action to address the remaining issues and ensure that their facility is in compliance with FDA standards.
The outcome of this inspection and the company’s response to the observations will be crucial in determining the future of Dr. Reddy’s Laboratories’ biologics manufacturing operations in the U.S. market. The company will need to demonstrate their ability to comply with FDA regulations and ensure the quality and safety of their products. Dr. Reddy’s Laboratories has not provided further details on the specific observations or their plans to address them, but the company has stated that they will work to resolve the issues within the stipulated timeline.