RUA Medical (Irvine)October 18, 2018

FDA 483 - RUA Medical (Irvine) - October 18, 2018

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Record Details

RUA Medical (Irvine) received a Form FDA 483 following an inspection from October 15-18, 2018. The inspection identified one observation concerning the firm's quality audit procedures. Specifically, the procedures were not adequately established to evaluate the effectiveness of the quality system, including record completeness, accuracy, and review processes.

Company: RUA Medical (Irvine)
Inspection Date: October 18, 2018
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: John A. Sciacchitano (investigator)

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ID · 76c3d9db-49cf-40dd-9e27-b979da667f7b