FDA 483 - McPherson Enterprises, Inc., dba Implantable Devices - September 06, 2023

An FDA inspection of McPherson Enterprises, Inc., dba Imp'lantable Devices in Pinellas Park, FL, revealed four significant deficiencies in their manufacturing processes for carotid shunt devices. These issues include a lack of established acceptance criteria for validation, inadequate risk analysis, insufficient supplier control procedures, and a failure to control environmental storage conditions. All observations were repeats from previous inspections, indicating persistent non-compliance.