Dr. Reddy’s Laboratories has been issued three observations by the U.S. Food and Drug Administration (U.S. FDA) after an inspection of its facility in Srikakulam, Andhra Pradesh.

The U.S. FDA has completed a Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection at the FTO-SEZ Process Unit-02 in Srikakulam. The inspection was conducted between July 20 and July 29, the Hyderabad-based generic drugmaker said in a filing on Wednesday (July 29, 2026).

“We have been issued a Form 483 with three observations, which we will address within the stipulated timeline,” Dr. Reddy’s said. The company’s shares closed flat on Thursday (July 30, 2026) at ₹1,144.35 a piece on the Bombay Stock Exchange.

Published - July 30, 2026 07:17 pm IST