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J&J Cypher warning letter update

This article was originally published in The Gray Sheet

Executive Summary

Johnson & Johnson/Cordis expects a "final resolution" of several Cypher drug-eluting stent-related GMP violations by the first half of 2005 at the latest, VP-Investor Relations Helen Short said during a Sept. 13 session of the Bear Stearns Healthcare Conference in New York (1"The Gray Sheet" April 12, 2004, p. 3). Cited in an FDA warning letter April 1, the violations included a lack of timely failure analysis reports on thrombosis complaints. J&J is in discussions with the agency about the timing of follow-up inspections at facilities cited in the letter, Short noted, adding that they center around whether FDA would expect 100% completion of corrective measures by the time inspectors arrive or just a demonstration that it is "making progress and would complete things in a reasonable time"...

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