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Dr Reddy's gets 2 observations from USFDA for Telangana API plant

USFDA completed a GMP inspection at the company's API manufacturing facility (CTO-5) in Miryalaguda, Telangana, the Hyderabad-based drug maker said in late evening filing on Saturday

Dr Reddy's Laboratories has received Form 483 with two observations after the US health regulator inspected its API manufacturing plant in Telangana.

The US Food & Drug Administration (USFDA) completed a GMP inspection at the company's API (active pharmaceutical ingredients) manufacturing facility (CTO-5) in Miryalaguda, Telangana, the Hyderabad-based drug maker said in a late evening filing on Saturday.

The USFDA inspected the plant from May 19 to May 24, 2025, it added.

"We have been issued a Form 483 with 2 observations, which we will address within the stipulated timeline," Dr Reddy's Laboratories said. As per USFDA, Form 483 is issued to a firm's management after an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related acts.

A GMP (Good Manufacturing Practice) inspection, also known as a GMP audit, is a thorough examination of a manufacturer's facility and operations to verify compliance with quality standards and regulations. These inspections assess aspects like manufacturing procedures, documentation, and employee training, ensuring products are safe and of consistent quality.

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