483
Cardinal Health 414, LLCCardinal Health 414, LLC – FDA 483, Sep 12, 2025
Record Details
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.
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ID · b19c8f0a-7db6-4063-9417-a60a4caceb87
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