USFDA issues seven observations to Dr Reddy's Hyderabad manufacturing plant

As per USFDA, Form 483 is issued to a firm's management at conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the FD&C Act

dr reddy's laboratory , dr reddy , drl pharma sector
The inspection was conducted from November 13-19, 2024. | File Photo
Press Trust of India New Delhi
1 min read Last Updated : Nov 19 2024 | 7:40 PM IST

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.

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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Topics :Dr Reddy's USFDAUSFDADr Reddy's Laboratories Limited

First Published: Nov 19 2024 | 7:39 PM IST

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