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