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Cypher Warning Letter Cites Systemic GMP Problems At Multiple Facilities

This article was originally published in The Gray Sheet

Executive Summary

Johnson & Johnson/Cordis' inability to provide timely failure analysis reports of Cypher-related thrombosis complaints is one of several GMP violations cited in an April 1 FDA 1warning letter

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The House Energy and Commerce Committee sent letters to FDA and Johnson & Johnson Aug. 13 requesting documents as part of an inquiry into FDA's Office of Regulatory Affairs

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Johnson & Johnson's stent subsidiary finally resolves a 2004 corporate warning letter with FDA June 14. Agency inspectors had cited Cordis for quality systems noncompliance, particularly issues relating to handling of safety complaints with the Cypher drug-eluting stent at five different facilities (1"The Gray Sheet" April 12, 2004, p. 3). The company does not expect any new FDA approvals soon as a direct result of the warning letter resolution; Cordis' Precise carotid stent had been held up by the warning letter, but that product was approved last October...

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