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

During an FDA inspection conducted from September 5-8, 2023, DUSA Pharmaceuticals, Inc., located in Billerica, MA, received a Form FDA 483 due to significant deficiencies in its complaint handling system. The inspection revealed that the company's procedures for receiving, reviewing, and evaluating complaints were inadequate, specifically failing to align with regulatory requirements under 21 CFR 820 for medical devices. A key issue identified was that DUSA's Complaint Handling procedure (SOP002725, Version 4.0) did not explicitly require documenting oral complaints or evaluating them for potential Medical Device Reporting (MDR) under 21 CFR 803. Furthermore, the company demonstrated a failure to uniformly process complaints for its photodynamic therapy products (Levulan® Kerasticks® and BLU-U Light). Investigators found that only one out of seven serious events reported since 2019 was properly logged into the complaint management system. Additionally, the firm failed to document required attempts to retrieve missing information for at least four complaints, despite their own procedure stipulating such actions. In response to these observations, DUSA Pharmaceuticals, Inc. reportedly "Promised to correct" the identified issues, indicating a commitment to revise their complaint handling procedures and ensure compliance with FDA regulations.