Laurus Labs' US Subsidiary Under USFDA Inspection

Laurus Labs, a prominent name in the pharmaceutical sector, recently disclosed that its US-based subsidiary, Laurus Generics Inc, has been issued a Form 483 by the US Food and Drug Administration (USFDA). This development follows a detailed inspection conducted over four days, from January 13 to January 21, 2025, at the subsidiary's facility in Berkeley Heights, New Jersey.

Scope of the Inspection

The inspection was comprehensive, focusing on the practices and procedures Laurus Labs employs for reporting adverse events related to its marketed products worldwide. The USFDA's issuance of Form 483, which outlines one observation, underscores the regulatory body's commitment to ensuring pharmaceutical safety and compliance.

Laurus Labs' Response

In response to the USFDA's observation, Laurus Labs has affirmed its commitment to addressing the issue within the stipulated timelines. The company's proactive stance highlights its dedication to maintaining high standards of safety and regulatory compliance in its operations.