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Meridian Bioscience CEO John Kraeutler: How We Turned Around A Deficient Quality System

This article was originally published in The Silver Sheet

Executive Summary

Meridian Bioscience’s quality system and company culture needed to change after the firm ran into regulatory trouble between 1999 and 2001, according to CEO John Kraeutler. “What I learned during those two years is, if you tell the FDA you’re going to do something, you really ought to do it,” he said. Meridian feared it was on the precipice of a consent decree with FDA and knew it had to act quickly. As a part of its culture change, the firm began urging employees to communicate important information to top management.

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