New Delhi, Nov 19 (PTI) 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) today 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.

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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.

(The above story is verified and authored by Press Trust of India (PTI) staff. PTI, India’s premier news agency, employs more than 400 journalists and 500 stringers to cover almost every district and small town in India.. The views appearing in the above post do not reflect the opinions of LatestLY)