Loading…
Sircle Laboratories, LLC manufactured adulterated drug products due to significant Current Good Manufacturing Practice (CGMP) violations identified during an April 2021 FDA inspection of its Madison, Mississippi facility. The company's quality control unit failed to exercise adequate oversight and responsibility to ensure drug products met established specifications for identity, strength, quality, and purity, and the firm lacked appropriate procedures to manage contract manufacturing organizations (CMOs) used for manufacturing, packaging, and distribution. The company failed to follow its own established quality unit procedures and commitments documented in quality agreements, with particular deficiencies in oversight and controls for its CMOs, which resulted in the use of sub-standard contractors.