FDA 483 - Cardinal Health 414 LLC - November 08, 2018

Cardinal Health 414 LLC in Tampa, FL, a PET Drug Manufacturer, was cited for inadequate facilities to prevent contamination during an FDA inspection. The firm failed to evaluate and mitigate the risk of cross-contamination from ongoing adjacent construction activities. Additionally, there was incomplete documentation for HVAC maintenance, which contributed to fungal contamination in ISO 5 areas where sterile injectable PET drug products are manufactured.