FDA 483 - Noah Medical Corporation - November 26, 2024

Noah Medical Corporation in San Jose, CA, received a Form FDA 483 with 13 observations during an inspection from 10/26/2024 to 11/26/2024. The inspection revealed significant deficiencies in medical device reporting, complaint handling, CAPA procedures, design controls, process validation, supplier management, nonconforming product control, rework procedures, device history records, correction/removal reporting, personnel training, and UDI database registration for their Galaxy System. These issues indicate a systemic breakdown in their quality system, particularly concerning patient safety and regulatory compliance.