Dr. Reddy’s Laboratories Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) has completed a Pre-License Inspection (PLI) at the company’s biologics manufacturing facility located in Bachupally, Hyderabad.
According to the company’s regulatory filing, the inspection was conducted from June 16 to June 25, 2026. At the conclusion of the inspection, the USFDA issued a Form 483 containing seven observations.
Dr. Reddy’s stated that it will address all the observations within the stipulated timeline prescribed by the USFDA. The company has not disclosed the specific nature of the observations in its filing.
The latest inspection follows previous USFDA inspections at the same facility. Dr. Reddy’s noted that this disclosure is in continuation of its earlier communications to the stock exchanges regarding inspections conducted in October 2023 and September 2025.
A Form FDA 483 is issued when FDA investigators identify conditions that may require corrective action during an inspection. The issuance of a Form 483 does not constitute a final regulatory action or indicate that a product or facility has been found to violate regulatory requirements. Companies are typically expected to submit a detailed response outlining corrective and preventive actions to address the observations.
Further details regarding the seven observations have not been made public.
