FDA 483 - Cardinal Health 414, LLC - August 03, 2018

Cardinal Health 414, LLC, a PET drug manufacturer in New Orleans, LA, received a Form 483 for significant deficiencies in equipment procedures, environmental monitoring, and aseptic processing. The inspection revealed inadequate controls for ensuring equipment suitability and sterility, as well as facility conditions and personnel practices that could lead to product contamination. These issues pose a risk to the quality and purity of PET drugs manufactured at the facility.