USFDA Inspection: Dr Reddy's gets Form 483 with 7 observations for Bollaram facility
New Delhi: Dr Reddy's Laboratories Ltd on Tuesday said the US health regulator has issued a Form 483 with seven observations to its active pharmaceutical ingredient manufacturing facility in Bollaram, Hyderabad.
"The US Food & Drug Administration (USFDA) on November 19, 2024 completed a GMP inspection at our API manufacturing facility (CTO-2) in Bollaram, Hyderabad," Dr Reddy's Laboratories Ltd (DRL) said in a regulatory filing.
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The inspection was conducted from November 13-19, 2024, it added.
"We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline," the company said.
As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of 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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