FDA 483 - Kabe Labortechnik Gmbh - January 09, 2025

An FDA inspection of Kabe Labortechnik Gmbh in Numbrecht, Germany, from January 6-9, 2025, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for design control, corrective and preventive actions, process validation, and supplier management. These issues indicate a systemic lack of control over critical manufacturing processes and product quality for devices like the Safe-T-Fill Capillary Blood Collection System.