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This article was originally published in The Gray Sheet

Executive Summary

Plans to file a response within the next week to an FDA Form 483 report stemming from a three-week re-inspection of manufacturing plants for the company's OraSure oral specimen collection device. The report contained 17 observations, "most" of which pertain to problems with "machinery controls, control samples and sample sizes for quality control testing," and "minor changes to procedures, to the work instructions for those procedures and to record keeping for certain procedures" at the company's Beaverton and Troutdale, Oregon facilities, Epitope says. During the original inspection for the manufacturing plants in December and January, FDA issued a 483 with 57 observations ("The Gray Sheet" Feb. 28, p. 6). In May, the company reported that FDA had sent the firm a letter outlining the "final steps required for FDA action" on the firm's OraSure premarket approval application, which was submitted in April 1991

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