Hyderabad-based drug major Dr Reddy's Laboratories Ltd on Friday (June 7) said the United States Food & Drug Administration (FDA) has issued Form 483 with four observations for its active pharmaceutical ingredient (API) manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh.
"This is to inform you that the United States Food & Drug Administration (USFDA) today completed a GMP inspection at our API manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh," Dr Reddy's Laboratories said in a regulatory filing.
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"The inspection was conducted from May 30, 2024, to June 7, 2024. We have been issued a Form 483 with four observations, which we will address within the stipulated timeline," the company said.
What is Form 483
Form 483 is a list of observations made during the inspection and is issued by the FDA inspectors after the completion of the inspection. The inspector communicates and explains 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. After Form 483 is issued, the company is given 15 days to submit its response to the FDA explaining what steps the company will take to resolve the observations.
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Shares of Dr Reddy's Laboratories Ltd ended at ₹6,037.55, up by ₹140.50, or 2.38%, on the BSE.
"This is to inform you that the United States Food & Drug Administration (USFDA) today completed a GMP inspection at our API manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh," Dr Reddy's Laboratories said in a regulatory filing.
Also Read: Wardwizard Innovations bags $1.29-billion EV order from Philippines company
"The inspection was conducted from May 30, 2024, to June 7, 2024. We have been issued a Form 483 with four observations, which we will address within the stipulated timeline," the company said.
What is Form 483
Form 483 is a list of observations made during the inspection and is issued by the FDA inspectors after the completion of the inspection. The inspector communicates and explains 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. After Form 483 is issued, the company is given 15 days to submit its response to the FDA explaining what steps the company will take to resolve the observations.
Also Read: Welspun Enterprises settles dispute with Indian Oil Corp, to receive ₹23.67 crore
Shares of Dr Reddy's Laboratories Ltd ended at ₹6,037.55, up by ₹140.50, or 2.38%, on the BSE.
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