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FDA's Risk-Based Approach To Facility Inspections Undergoing Refinements

This article was originally published in The Silver Sheet

Executive Summary

FDA IS REVIEWING ITS RISK-BASED INSPECTION APPROACH to make sure it is learning all it can about problematic manufacturers and devices. The agency weighs product and manufacturer risk when deciding which firms to inspect, but “we're working to improve our model,” says Larry Spears, deputy director of regulatory affairs in CDRH's Office of Compliance. “We want to get input from other parts of the agency, particularly the Office of Regulatory Affairs, to help us make sure that we're truly identifying all risk.” Speaking from the trenches, Baltimore District Office device investigator Lori Lawless tells manufacturers what to expect during an FDA inspection. Because investigators use FDA's publicly available Quality System Inspection Technique, “there should really be no reason why an FDA-483 form needs to be issued,” she says.

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