FDA 483 - E5 Pharma LLC - February 17, 2023

E5 Pharma LLC, a labeler/relabeler in Boca Raton, FL, was cited for significant deficiencies in its pharmacovigilance system. The firm failed to report an adverse drug experience within the required timeframe and submitted incomplete periodic reports. Additionally, the company lacked adequate written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences.