Dr. Reddy's Biologics Unit in Hyderabad Gets 7 USFDA Observations After Pre-Licence Inspection
The U.S. Food and Drug Administration (USFDA) has issued seven observations to the biologics manufacturing facility of Dr. Reddy's Laboratories in Bachupally, Hyderabad, following a pre-licence inspection (PLI) conducted from June 16 to June 25, 2026.
A Form 483 detailing the observations was issued upon completion of the inspection, the generic drugmaker confirmed in a regulatory filing on Thursday. Dr. Reddy's stated that it would address the observations within the stipulated timeline.
The facility had undergone previous inspections in October 2023 and September 2025, during which the USFDA issued Form 483s with nine and five observations, respectively. The company has a history of responding to such observations and resolving them to the regulator's satisfaction.
Form 483 is a notice issued by the USFDA to a company when its investigators observe conditions that may violate the Food, Drug, and Cosmetic Act. It is not a final determination of non-compliance but requires a written response outlining corrective actions.
Dr. Reddy's Laboratories is one of India's leading pharmaceutical companies, with a significant presence in the biologics segment. The company's biologics facility in Hyderabad manufactures complex therapeutic proteins and biosimilars for global markets.
