FDA 483 - Sircle Laboratories, L.L.C. - September 16, 2022

Sircle Laboratories, L.L.C., an Own Label Distributor in Madison, MS, was inspected and cited for significant deficiencies in its quality control unit, personnel training, and record-keeping practices. The inspection revealed a systemic lack of written procedures and failure to follow existing ones, particularly concerning quality unit responsibilities, document control, vendor qualification, and employee training. These issues indicate a fundamental breakdown in the firm's adherence to current Good Manufacturing Practices.