Dr. Reddy’s Laboratories announced that the United States Food & Drug Administration (USFDA) has completed a Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection at its FTO-SEZ Process Unit-02 in Srikakulam, Andhra Pradesh. The inspection took place between July 20, 2026, and July 29, 2026. The company received a Form 483 with three observations, which it plans to address within the stipulated timeline.
USFDA Inspection Concluded
Dr. Reddy’s Laboratories has received notification from the United States Food & Drug Administration (USFDA) regarding the completion of an inspection at its facility located in Srikakulam, Andhra Pradesh. The inspection covered both Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) at the company’s FTO-SEZ Process Unit-02.
Inspection Details and Outcomes
The comprehensive inspection was conducted over a period of ten days, from July 20, 2026, to July 29, 2026. Following the inspection, Dr. Reddy’s Laboratories was issued a Form 483. This document outlines three specific observations made by the USFDA inspectors. The company has committed to addressing these observations within the timelines that have been stipulated.
Commitment to Compliance
Dr. Reddy’s Laboratories emphasizes its dedication to maintaining high standards of compliance and manufacturing practices. The company will provide further updates as necessary regarding the resolution of the observations made during this inspection. This disclosure is provided for informational and record-keeping purposes.
Source: BSE
