FDA 483 - Cardinal Health 414, Inc. - January 25, 2018

Cardinal Health 414, Inc. in Seattle, WA, a PET Drug Manufacturer, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate personnel training for visual inspection of sterile products, deficient aseptic practices during manufacturing, and unsuitable laboratory analytical methods for microbial identification. The firm also failed to thoroughly investigate non-conformances and Out of Specification results, indicating a need for improved quality control and manufacturing processes.