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

An FDA inspection of Cardinal Health 414, LLC in Indianapolis, IN, revealed significant deficiencies in quality control and facility maintenance. The firm failed to thoroughly investigate out-of-specification results and microbial contamination, and its sampling methods for bioburden testing were found to be unrepresentative. Additionally, critical production line equipment was damaged and lacked proper repair documentation, indicating a risk to drug product quality and safety.