Sircle Laboratories, L.L.C. – FDA 483, Sep 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.