FDA 483 - Cardinal Health 414, LLC - September 12, 2025

Cardinal Health 414, LLC in Indianapolis, IN, received a Form 483 with three observations related to manufacturing practices for radiopharmaceutical drug products. The inspection revealed failures in thoroughly investigating unexplained discrepancies, non-representative sampling for bioburden testing, and inadequate maintenance of equipment on the production line. These issues indicate potential risks to the safety, identity, strength, quality, or purity of their drug products.