FDA 483 - Tex-Care Medical - December 15, 2023

Tex-Care Medical in Burlington, NC, was inspected by the FDA, resulting in three observations related to its quality system. The firm failed to adequately establish and document procedures for device history records, including a lack of clear definitions and missing documentation for finished device acceptance and in-process inspections of impervious stockinettes. Additionally, procedures for quality audits were not adequately established, specifically regarding the auditing of Device History Records within the Quality Management System.