FDA 483 - 3D Medical Manufacturing, Inc. - August 15, 2025

An FDA inspection of 3D Medical Manufacturing, Inc. in Riviera Beach, FL, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, properly investigate complaints, control nonconforming products, and document process validation activities. These issues indicate systemic problems in maintaining a compliant quality management system.