FDA 483 - Carolina Biological Supply Co - September 23, 2022

Carolina Biological Supply Co in Burlington, NC, was inspected from September 19-23, 2022, revealing significant deficiencies across its quality system. The firm lacked adequate procedures for corrective and preventive actions, medical device reporting, document control, process controls, quality audits, and employee training. These issues indicate a broad lack of established and followed quality management practices.