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Cardinal Health inks amended consent decree with FDA

This article was originally published in The Gray Sheet

Executive Summary

Firm's amended consent decree with FDA expands its scope to include all Alaris infusion pumps, calling for the correction of good manufacturing practice violations. The pumps are made by a division of Cardinal Health formerly known as Alaris Medical Systems, which was acquired in 2004 and subject to the initial consent decree in February 2007 to resolve a 2006 seizure of Alaris SE infusion pumps (1"The Gray Sheet" Feb. 12, 2007, p. 5). FDA alleges in the amended consent decree that based on a January 2008 inspection, certain Cardinal Health infusion pumps do not satisfy agency standards, according to Cardinal. The firm says it implemented a new quality system in April 2008. Now the firm must hire an independent expert consultant to inspect all of its infusion pump facilities and recall procedures, and certify to FDA that corrective actions have been made. The amended decree, which includes the Alaris System, Gemini and Med System III infusion pumps, remains subject to approval by the U.S. District Court for the Southern District of California. If there are "future violations," FDA says it may suspend manufacturing and distribution
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