483
Cardinal Health 414 LLCCardinal Health 414 LLC – FDA 483, Apr 3, 2026
Record Details
An FDA inspection of Cardinal Health 414 LLC in Memphis, TN, revealed a significant issue with equipment suitability. The firm failed to implement procedures and document activities to ensure equipment is suitable for its intended purposes, specifically regarding a low-temperature incubator. This lapse led to the continued use of a malfunctioning incubator for critical samples without proper requalification, potentially affecting the quality of PET drugs.
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ID · df8baf5c-d499-47e5-a6d6-4010ec023f24
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