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Fresenius USA complaint handling procedures are inadequate -- FDA warning letter.

This article was originally published in The Gray Sheet

Executive Summary

FRESENIUS USA HEMODIALYZER/REPROCESSOR UNANTICIPATED DEVICE FAILURES should have been categorized by the company as complaints and investigated pursuant to good manufacturing practices (GMP) requirements, FDA says in a May 25 warning letter to the Walnut Creek, California-based firm. Review of service repair records for 40 Model 2008E and 55 Model 2008H hemodialysis machines, manufactured between March 1993 and March 1994, "showed at least 30 unanticipated device failures which were not identified, reviewed or evaluated as complaints," FDA says. In addition, review of service repair records for five Fresenius DRS-4 dialyzer reprocessing systems "found at least 11 reports of unanticipated device failures" that were not treated as complaints.

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