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FDA Eyes Inspectional Form Changes As SOP Troubles Top FDA-483 Citations In 2013

This article was originally published in The Silver Sheet

Executive Summary

The way inspectional observations are presented on FDA-483 forms might be modified under a new FDA pilot program. The goal is to help device companies prioritize corrective actions to avoid potentially serious quality system troubles. The agency decided it was time to reassess how its investigators list observations on the forms after talking with industry device quality experts. The potential change comes at a time when FDA issued a record number of FDA-483s to firms last year, many of which indicated problems with procedures in a variety of quality system areas.

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