FDA 483 - McPherson Enterprises, Inc., dba Implantable Devices - October 29, 2021

An FDA inspection of McPherson Enterprises, Inc., dba Implantable Devices, in Pinellas Park, FL, revealed four significant deficiencies, including repeat observations related to validation activities, risk analysis, and environmental controls. The firm failed to establish acceptance criteria for validation, adequately identify design failure causes, properly evaluate suppliers, and monitor environmental conditions for device storage. These issues indicate a concerning lack of adherence to quality system requirements for medical device manufacturing.