FDA 483 - BihlerMed, LLC - November 30, 2023

BihlerMed, LLC in Phillipsburg, NJ, was inspected by the FDA from November 15-30, 2023, and received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in quality system procedures, specifically regarding the control of nonconforming product, design change management, and the establishment of design inputs for their medical devices. These issues indicate a lack of adequate controls to ensure product quality and safety.