Dr Reddy's Receives 3 USFDA Observations at Srikakulam Facility
New Delhi: Dr. Reddy's Laboratories has informed stock exchanges that the United States Food and Drug Administration (USFDA) has completed a Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection at its FTO-SEZ Process Unit-02 located in Srikakulam, Andhra Pradesh.
According to the company's regulatory filing, the inspection was conducted from July 20 to July 29, 2026. At the conclusion of the inspection, the USFDA issued a Form 483 containing three observations.
Dr. Reddy's stated that it will respond to the observations within the stipulated timeline in accordance with regulatory requirements. The company did not disclose the nature of the observations in its filing.
A Form 483 is issued by the USFDA when investigators identify conditions that may require corrective action. The observations are preliminary in nature and do not represent a final regulatory determination. Companies are expected to submit detailed corrective and preventive action plans to address the observations.
