FDA 483 - George Taub Products & Fusion Co., Inc. - November 20, 2024

George Taub Products & Fusion Co., Inc. in Jersey City, NJ, was inspected and cited for numerous deficiencies in its quality system. The inspection revealed significant issues across device master records, production processes, personnel training, CAPA documentation, design risk analysis, MDR procedures, supplier control, quality audits, and management reviews. These observations indicate a broad lack of adherence to established procedures and regulatory requirements for medical device manufacturing.