FDA 483 - DUSA Pharmaceuticals, Inc. - September 08, 2023

An FDA inspection of DUSA Pharmaceuticals, Inc. in Billerica, MA, revealed significant deficiencies in the firm's complaint handling procedures. The company failed to adequately establish procedures for receiving, reviewing, and evaluating complaints, including not documenting oral complaints or evaluating them for medical device reporting requirements. Furthermore, DUSA Pharmaceuticals did not uniformly handle complaints for its photodynamic therapy products, neglecting to log multiple serious events into its complaint management system.