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•Cardinal Health 414, LLC•September 12, 2025

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

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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.

Company
Cardinal Health 414, LLC
Inspection Date
September 12, 2025
Product Type
Drugs
Office
Detroit District Office
People
  • Carolina D. Vasquez
  • Rowena S. Nguyen
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ID · b19c8f0a-7db6-4063-9417-a60a4caceb87

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