FDA 483 - Delcath Systems Inc. - June 09, 2023

An FDA inspection of Delcath Systems Inc., a manufacturer of Hepatic Drug Delivery Systems in Queensbury, NY, revealed three significant observations. The firm failed to submit an MDR report for a serious injury, inadequately documented corrective and preventive actions for a sterilization process failure, and lacked clear purchasing data specifications for a critical component. These issues indicate deficiencies in their quality system.