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Epitope

This article was originally published in The Gray Sheet

Executive Summary

Successfully completes FDA preapproval reinspection of its Beaverton, Oregon facility for manufacturing the OraSure oral sample collection device for HIV diagnosis. The agency concluded its inspection "without finding it necessary to issue a form 483 notice of deficiencies," the firm reports. Following the inspection, company officials met with FDA to discuss "finalizing product labeling and defining appropriate post-approval studies" for OraSure, Epitope says. After its previous re-inspection, Epitope received a Form 483 notice in September citing 17 deficiencies. The original inspection last May led to a 483 with 57 agency observations. A premarket approval application for the Orasure was filed in April 1991
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