Dr. Reddy’s Laboratories has announced that the United States Food & Drug Administration (USFDA) has issued a Form 483 with five observations following a Pre-Approval Inspection (PAI) at its biologics manufacturing facility in Bachupally, Hyderabad.
The inspection was carried out between September 4 and September 12, 2025, and officially concluded on September 12, 2025. The company confirmed that it will address the five observations within the stipulated timeline provided by the USFDA.
This inspection is linked to a prior review at the same site, which Dr. Reddy’s had earlier disclosed to the stock exchanges on October 12, 2023.
A Form 483 is issued by the USFDA when inspectors observe conditions that may constitute violations of the Food Drug and Cosmetic Act and related regulations. Companies are required to respond within a set period to ensure compliance.
Dr. Reddy’s emphasized that it is committed to working closely with the regulator to resolve the observations and ensure that its manufacturing operations meet the highest standards of quality and compliance.
