FDA Makes Two Observations On Dr Reddy’s plant

New Delhi: 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 USFDA inspected the plant from May 19 to May 24, 2025, it informed.

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.