Hyd-based Dr Reddy’s gets 2 observations from USFDA for Telangana API plant

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

New Delhi: Dr Reddy’s Laboratories has received a 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.

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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.