FDA 483 - Jerome Stevens Pharmaceuticals, Inc. - April 11, 2019

An FDA inspection of Jerome Stevens Pharmaceuticals, Inc. in Bohemia, NY, revealed significant deficiencies in their postmarketing adverse drug experience reporting system. The firm lacked adequate written procedures for surveillance, evaluation, and reporting of adverse drug events, and failed to submit required periodic reports and timely 15-day alert reports. These issues indicate a systemic failure to comply with adverse drug event reporting regulations.