FDA 483 - Easy Healthcare Corporation - August 24, 2018

An FDA inspection of Easy Healthcare Corporation, a distributor and initial importer of medical devices, was conducted from August 21 to 24, 2018. The inspection identified significant deficiencies in the company's quality system, detailed in a Form FDA 483. Key observations included a lack of clearly defined control over purchased products, such as TENS units and pregnancy tests, with products distributed without acceptance activities. The firm also failed to select suppliers based on specified requirements, lacking proper supplier evaluations, quality agreements, and an approved supplier list. Furthermore, Easy Healthcare Corporation did not maintain adequate records for medical device corrections, specifically concerning widespread battery failures in basal thermometers where only complaining customers received replacements. Procedures for corrective and preventive actions were found inadequate, as they lacked systematic quality data analysis and failed to address root causes of identified problems. Finally, the firm's complaint handling system was deficient, with not all complaints documented, hindering complete investigations. Easy Healthcare Corporation is responsible for addressing these observations to ensure compliance with medical device quality system regulations.