483
Laurus Generics, Inc.Laurus Generics, Inc. – FDA 483, Jan 21, 2025
Record Details
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.
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ID · e0a2dac7-8763-4329-867a-18832f9fd8c5
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