FDA 483 - Sircle Laboratories, L.L.C. - April 26, 2021

An FDA inspection of Sircle Laboratories, L.L.C. in Madison, MS, an own label distributor, revealed significant deficiencies in its quality control unit. The firm failed to adequately oversee contract manufacturers, approve drug product releases, and maintain proper written procedures for critical operations like batch release, vendor qualification, and change control. Several observations, including issues with quality control responsibilities and labeling procedures, were noted as repeat findings, indicating persistent compliance issues.