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Cobe Renal Care, Terumo Medical receive warning letters for GMP violations.

This article was originally published in The Gray Sheet

Executive Summary

COBE RENAL CARE ARRANGING CONSULTANT AUDIT OF DIALYSIS SYSTEM GMPs at its Lakewood, Colorado facility in order to determine whether the firm has addressed good manufacturing practices problems outlined by FDA in a warning letter issued April 16. As instructed by FDA, Cobe has contacted an outside consultant and scheduled an audit of its manufacturing and quality assurance systems to determine compliance with GMP regulations. The company says it is on track to meet an Oct. 1 deadline for submission of the consultant's GMP compliance certification to FDA.



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