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Agency claims Deerfield, Ill,-based firm is using misleading device labeling and isn't complying with federal manufacturing standards.
October 21, 2009
By: Editor
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The U.S. Food and Drug Administration has issued a warning letter to Deerfield, Ill.-based Baxter International Inc., alleging misleading labeling of an unidentified device and noncompliance with federal manufacturing standards. “Management with executive responsibility failed to ensure that the quality policy is understood, implemented and maintained at all levels of the organization,” said the agency in the warning letter, which was sent to Baxter Sept. 10. Baxter International wasn’t immediately available for comment. Go towww.fda.gov/ICECI/EnforcementActions/WarningLetters/ ucm186835.htm to view the complete warning letter.
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