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Does Your CAPA Process Need a CAPA?

Global Medical Device Podcast powered by Greenlight Guru

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What Does Multiple Complaints Mean?

" 95 to 97 percent of adverse events are never rewarded," he says. "If you get a complaint or a series of complaints, and for whatever reasons, we're not going to have a cap" FDA inspector: No documentation exists explaining why a cap was not initiated upon learning of the problem.

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