FDA 483 - 4FRONT Solutions, LLC - June 12, 2019

4FRONT Solutions, LLC, a medical device contract manufacturer in Deland, FL, was cited for significant deficiencies across its quality system during an FDA inspection. The firm failed to adequately validate processes and software, establish proper change control procedures, and maintain records for final inspection and device history. Widespread issues were noted in complaint handling, CAPA, nonconforming product control, supplier management, quality audits, document approval, and employee training, indicating a fundamental breakdown in the firm's quality management system.