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Warning Letter Roundup & Recap

This article was originally published in The Silver Sheet

Executive Summary

Zoll cited for QS and MDR violations; FDA instructs maker of drug-of-abuse kits to hire a consultant to audit the firm’s manufacturing and quality assurance systems; Ambco Electronics failed to fully investigate and document device failures. Eight quality-related warning letters were listed by FDA from Sept. 12 through Oct. 14.

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