Delcath Systems Inc.June 9, 2023

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

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Record Details

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.

Company: Delcath Systems Inc.
Inspection Date: June 9, 2023
Product Type: Device
Office: Division of Human and Animal Food Operations - East I
Person: Jacqueline S. Warner

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ID · 15fb5b0b-2b40-469b-98db-cb56aeca0433