FDA: Out-Of-Spec Components May Be Used In Finished Devices – But Beware
• By Shawn M. Schmitt
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.
[Editor's note:This feature is the first in a new series, "Quality Replay," where we dig into our rich digital archives for perennial insights on quality compliance topics. The full version of this article
first appeared in our former sister publication The Silver Sheet in August 2010. The content has been edited from its original form and the advice within deemed still relevant...
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