FDA 483 - Cardinal Health 414, Inc. - February 25, 2020

Cardinal Health 414, Inc. in Seattle, WA, a PET drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included inadequate production and process controls with poor aseptic practices, failure to take appropriate corrective actions for expired operator requalifications, and insufficient investigation of non-conformances and Out of Specification test results. These issues indicate a lack of robust quality assurance and control over sterile drug manufacturing.