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BioWorld - Sunday, June 21, 2026
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Home » US FDA drops warning on Cardinal Health over third party devices
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US FDA drops warning on Cardinal Health over third party devices

May 1, 2024
By Mark McCarty
The U.S. FDA issued a handful of warning letters to device makers in the month of April 2024, one of which is for the Waukegan, Il., plant operated by Cardinal Health Inc., of Dublin, Ohio. While the Waukegan plant escaped citations for most routine Quality System Regulation deviations, the FDA said Cardinal’s handling of contract manufactured luer locks and syringes fell well short of the agency’s expectations given that these issues led to a massive recall, a product removal and an FDA advisory.
Medical technology Regulatory U.S. FDA

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