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J&J Interventional Systems stent complaint investigation procedures deficient -- FDA warning letter.

This article was originally published in The Gray Sheet

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Executive Summary

JJIS' INADEQUATE INVESTIGATION OF STENT COMPLAINTS CITED BY FDA in a May 29 warning letter to Johnson & Johnson Interventional Systems' Warren, New Jersey facility. The agency says that an April 8 to 19 inspection of the facility revealed "serious violations" of good manufacturing practice regulations "concerning the processing and testing" of the firm's SDS stent delivery system used to deploy its market-leading Palmaz-Schatz coronary stent.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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