FDA 483 - Advanced Back Technologies, Inc. - October 31, 2024

An FDA inspection of Advanced Back Technologies, Inc. in Syosset, NY, a manufacturer of Class II medical devices, identified four significant quality system deficiencies. These observations primarily concern inadequate maintenance of device history records, lack of formal agreements with contractors for product change notifications, and deficiencies in established procedures for corrective and preventive actions and design changes. The findings indicate a need for improved documentation and procedural controls to ensure product quality and regulatory compliance.