Vonco Products, Inc. – FDA 483, Apr 10, 2025

Vonco Products, Inc. in Trevor, WI, a medical device manufacturer, received a Form FDA 483 with four observations following an inspection. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning procedures for controlling nonconforming product, process validation, design change, and design input for their Class II EnteraLoc Flow Spouted Pouches. These issues indicate a lack of adequate controls to ensure product quality and compliance with regulatory requirements.