FDA 483 - Cardinal Health 414 LLC - June 18, 2019

Cardinal Health 414 LLC in East Hartford, CT, was cited for inadequate control over the quality of supplies used in its testing procedures. The firm continued to utilize media for sterility testing of PET drug products despite documented quality issues such as leaking tubes, precipitation, and unknown particles. This lapse in quality control for critical testing materials was also evidenced by observed particulates in released media stock.