FDA 483 - Dukal Llc - September 27, 2019

Dukal Corporation in Ronkonkoma, NY, was cited for significant deficiencies in its complaint handling and incident/event evaluation procedures. The inspection revealed inadequate review of complaints, inconsistent risk assessment methodologies, and a lack of proper evaluation for Medical Device Reporting (MDR) reportability and corrective actions. These issues indicate a systemic failure to adequately address potential adverse events and ensure product safety.