FDA 483 - Elevate Textiles, Inc. - April 11, 2025

Elevate Textiles, Inc. in Burlington, NC, received a Form FDA 483 with six observations related to significant deficiencies in its quality system for Class II medical devices. The firm failed to establish and implement critical quality procedures, including design controls, CAPA, training documentation, and quality audits, despite manufacturing having commenced. These issues indicate a fundamental lack of a compliant quality management system.