Dr Reddy's Gets USFDA Observations for Telangana API Plant
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Dr Reddy's Laboratories received two observations from the USFDA after an inspection of its API manufacturing plant in Telangana. The observations were issued in the form of a Form 483, which indicates potential violations of US regulations.
New Delhi, May 25 (PTI) 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 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.
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 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.
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