“This is to inform you that the United States Food & Drug Administration (USFDA) today completed a GMP inspection at our API manufacturing facility (CTO-2) in Bollaram, Hyderabad,” according to a stock exchange filing.
The inspection, conducted from November 13 to November 19, 2024, concluded with the issuance of a Form 483 containing seven observations. Dr Reddy’s has stated its commitment to addressing these observations within the stipulated timeline, ensuring compliance with regulatory requirements.
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“The inspection was conducted from 13th November, 2024 to 19th November, 2024. We have been issued a Form 483 with 7 observations, which we will address within the stipulated timeline,” it said.
What is a Form 483
A Form 483 is a list of observations made during the inspection and is issued by the USFDA inspectors post the completion of the inspection. The inspector will communicate and explain these observations to the supplier during the closing conference. However, form 483 does not represent a final FDA determination regarding the facility’s GMP compliance.
Post Form 483 is issued, the company is given 15 days time to submit its response to the USFDA explaining what steps will the company take to resolve the observations made by the USFDA.
Shares of Dr Reddy’s Laboratories Ltd ended at ₹1,213.45, up by ₹20.10, or 1.68% on the BSE.
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