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FDA: Purchasing Control Troubles Causing Recalls; Approved Supplier Lists Lack Details

This article was originally published in The Silver Sheet

Executive Summary

FDA’s inspectional approach might change in an effort to curb recalls related to purchasing controls, the agency says. “Do I believe we need to highlight supplier control and purchasing control under our current compliance program and current way of inspecting? Absolutely,” said CDRH’s Kim Trautman, who is heading up FDA’s review of its Quality System Inspection Technique (QSIT). Agency investigators are already being trained to delve deeper into supplier control issues when conducting facility inspections. FDA also says that firms are falling down when creating detailed approved supplier lists. Many companies are “adding only the name of a vendor to an approved supplier list. That practice needs to be adjusted,” Trautman said. Meanwhile, manufacturer Welch Allyn describes how it is using “lean” principles to clean up its approved supplier list, which includes about 2,500 vendors.

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