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Warning Letter Roundup & Recap

This article was originally published in The Silver Sheet

Executive Summary

SmartMonitor battery pack troubles dog Philips Children’s Medical Ventures; maker of GenStrip glucose test strips cited for QS and MDR reg violations; the Portable Exchange Deionization System was labeled to meet the requirements of an outdated ANSI/AAMI standard. Nine quality-related warning letters were listed by FDA from Aug. 12 through Sept. 11.

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