FDA 483 - Cumberland Biotherapeutics LLC - June 27, 2024

Cumberland Biotherapeutics LLC, a medical device manufacturer in Sewanee, TN, was inspected by the FDA from June 25-27, 2024. The inspection revealed significant deficiencies in the firm's quality system, including a lack of established quality objectives, inadequate supplier control procedures, and the absence of a corrective and preventive action system. These findings indicate a fundamental breakdown in the firm's quality management practices.