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FDA: Out-Of-Spec Components May Be Used In Finished Devices – But Beware

This article was originally published in The Gray Sheet

Executive Summary

In our first "Quality Replay" feature, we look back at an educational article from August 2010: Device firms frequently adjust manufacturing processes to accommodate components that are out of specification, but that isn’t necessarily a problem as long as the product meets “finished device specifications and all of its labeling requirements,” FDA's Jan Welch says. During an agency inspection, FDA will check to see whether a firm’s manufacturing change is a one-time exception or if the company makes changes on a regular basis. “The occasional one-off situation for a component or material may be acceptable with justification,” Welch explains. A company will typically consider the type of component, its risk of possible failure and whether it’s critical to the proper functioning of the device when deciding whether to use out-of-specification components.

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