Drug firm Laurus Labs Ltd on Tuesday (December 12) said its wholly-owned subsidiary Laurus Synthesis Private Ltd (LSPL) underwent a comprehensive inspection by the US Food and Drug Administration (FDA) at its manufacturing facility in Parawada, Anakapalli, near Visakhapatnam, Andhra Pradesh.
The inspection, from December 4-12, 2023, culminated in the issuance of a Form 483 outlining five observations, Laurus Labs said in a regulatory filing.
"This is to inform you that Laurus Synthesis Private Limited (LSPL), a wholly owned subsidiary of Laurus Labs underwent US FDA inspection for the manufacturing facility in Parawada, Anakapalli, near Visakhapatnam, Andhra Pradesh. The inspection was conducted from 4th December 2023 to 12th December 2023," the company said.
Laurus Labs assured its stakeholders that the company is committed to addressing these observations promptly.
What is a Form 483?
A Form 483 is a list of observations made during the inspection and is issued by the USFDA 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 USFDA explaining what steps the company will take to resolve the observations made by the USFDA.
Shares of Laurus Labs Ltd ended at ₹390, down by ₹0.65, or 0.17%, on the BSE.
(Edited by : Shoma Bhattacharjee)
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