Delcath Systems Inc. – FDA EIR, Nov 9, 2016

An FDA inspection of Delcath Systems Inc., a manufacturer of medical devices in Queensbury, NY, was conducted on November 9, 2016. The inspection focused on the company’s "export only" medical device, the Hepatic CHEMOSAT Delivery System, and its investigational combination drug/device (Melphalan/Hepatic Delivery System) used in a Phase 3 clinical study and compassionate use programs. This was not a comprehensive Current Good Manufacturing Practice (cGMP) inspection, as the company does not commercially market any products in the U.S. No formal FDA 483 observations were issued during this inspection. However, one verbal observation was noted regarding the firm’s handling of incoming medical device components. Raw materials awaiting quality control inspection were not physically identified as "on hold" or "quarantined," posing a risk of uninspected materials entering production. Delcath Systems Inc. management promptly took voluntary corrective action by physically identifying the affected carton and committed to revising their incoming receiving procedures to address this issue. The inspection did not cover corrective actions from a previous 2013 FDA inspection, which resulted in seven observations related to inadequate design inputs, validation, process validations, and supplier controls. A pre-approval inspection will be required to verify compliance and marketing approval before the company can commercialize its product in the United States.