FDA 483 - Carolina Biological Supply Co - March 08, 2018

Carolina Biological Supply Co in Burlington, NC, was issued a Form FDA 483 following an inspection from March 6-8, 2018, citing four observations. The inspection revealed significant deficiencies in the firm's quality system, including a lack of established procedures for quality audits, management review, document control, and purchased product control. Additionally, the firm failed to develop written procedures for Medical Device Reporting, corrective and preventive actions, and complaint handling.