FDA 483 - Dukal Llc - April 11, 2018

Dukal Corp., an importer and specification developer of medical devices in Ronkonkoma, NY, was cited for significant deficiencies in its quality system. The inspection revealed failures in documenting corrective and preventive actions, inadequate control over products and suppliers, insufficient process validation documentation, and untimely reporting of device malfunctions. These issues highlight a lack of robust procedures for design control and post-market surveillance, particularly concerning burn sheets and other imported medical devices.