FDA 483 - Medynus Inc - December 17, 2024

Medynus Inc., a medical device manufacturer in Irvine, CA, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to establish adequate procedures for design validation, supplier controls, corrective and preventive actions, incoming product acceptance, and complaint handling, and also neglected to perform required internal quality audits. These issues indicate a systemic breakdown in maintaining a compliant quality management system for their Goblin Spinal Pedicle Screw System.