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Survey: Half Of Companies Throw Big Bucks At FDA-483 Observations, While Heads Roll At A Quarter Of Firms After Poor Inspection Results

This article was originally published in The Gray Sheet

Executive Summary

A survey of 310 industry stakeholders found that extra resources are given to functional areas singled out by agency investigators for noncompliance at 49% of device firms, but respondents also said additional assets don't always equate to improved device quality. "The challenge for us in the quality area is to ensure that we understand what the appropriate amount of staffing is once we reach development of the processes that we need, and what we need as far as resources to maintain those processes," Meridian Bioscience's Susan Rolih says. Meanwhile, 24% of survey-takers say employees are fired or penalized when there are poor inspection outcomes – a knee-jerk reaction that experts say can negatively affect worker morale. Also: An overwhelming majority of survey respondents, 68%, say investigators should list observations on an FDA-483 from major to minor; 66% say they address the riskiest FDA observations first; 93% tackle so-called "discussion items"; and more.

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