FDA EIR - Medical Murray Inc. - November 15, 2017

An FDA inspection of Murray, Inc. DBA Medical Murray, a contract manufacturer of Class II intravascular and airway catheters and related components, was conducted from November 14-15, 2017, in Lake Zurich, IL. This Level I inspection, guided by the Compliance Program Guidance Manual (7382.845) and Guide to Inspections of Quality Systems (QSIT), focused on the firm's corrective and preventive action (CAPA) and production and process controls for fluid delivery and dilation catheters. Notably, the inspection did not result in an FDA 483, signifying no formal observations of objectionable conditions. However, two critical discussion items were raised with management. These included the need to expand CAPA verification protocols to ensure the sustained effectiveness of corrective and preventive actions, and the absence of a specified timeframe for complaint evaluation within the firm's complaint handling procedure. Management at Medical Murray was cooperative and committed to addressing these discussion items to enhance their quality system procedures.