FDA 483 - Laurus Generics, Inc. - January 21, 2025

Laurus Generics, Inc. in Berkeley Heights, NJ, a corporate office, was inspected by the FDA from January 13-21, 2025. The inspection revealed a significant deficiency related to the firm's pharmacovigilance system. Specifically, the company lacked written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing adverse drug experiences.