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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

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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