FDA 483 - Marlex Pharmaceuticals, Inc. - August 12, 2021

Marlex Pharmaceuticals, Inc. in New Castle, DE, a drug repacker, relabeler, and distributor, was cited for significant deficiencies in its written procedures for handling postmarketing adverse drug experiences (PADE). The firm's standard operating procedures were found inadequate for the surveillance, receipt, record-keeping, evaluation, and reporting of adverse drug events, including issues with PADE definitions and electronic submission requirements. This indicates a critical lack of a robust pharmacovigilance system at the facility.