FDA 483 - Marson Medical, Inc. - January 16, 2026

Marson Medical, Inc., a contract manufacturer in Paramus, NJ, was cited for significant deficiencies across its quality system during an FDA inspection. The firm failed to adequately validate critical manufacturing processes for orthopedic implants, including ultrasonic cleaning and drying, and lacked proper controls for nonconforming products and customer complaints. Additionally, issues were noted in document control, process monitoring, device history records, internal audits, sampling plans, training, and corrective and preventive actions.