FDA 483 - Carolina Biological Supply Co - December 17, 2025

An FDA inspection of Carolina Biological Supply Co in Burlington, NC, a manufacturer, revealed a significant quality system deficiency. The firm's internal audit procedure was not followed, as the Quality Management Representative was auditing processes for which they had direct responsibility, indicating a lack of independence in quality oversight. Additionally, the internal audit process itself had not been audited, highlighting a systemic issue in their quality management system.