New Delhi, Jun 7 (PTI) Dr Reddy's Laboratories on Friday said the US health regulator has issued Form 483 with four observations after inspecting its Andhra Pradesh-based API manufacturing facility.

The US Food & Drug Administration (USFDA) today completed a GMP inspection at the company's API manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh, the Hyderabad-based drug major said in a regulatory filing.

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The inspection was conducted from May 30, 2024 to June 7, 2024, it added.

"We have been issued a Form 483 with four observations, which we will address within the stipulated timeline," the drug firm said.

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As per the 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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