ReNovo, Inc.June 18, 2018

FDA 483 - ReNovo, Inc. - June 18, 2018

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Record Details

ReNovo, Inc., a reprocessor in Bend, OR, was cited for deficiencies related to its supplier and contractor management. The inspection revealed inadequate documentation for the evaluation and approval of contractors, as well as a lack of formal agreements requiring suppliers to notify the firm of product or service changes. These issues indicate weaknesses in the firm's quality system regarding external party controls.

Company: ReNovo, Inc.
Inspection Date: June 18, 2018
Product Type: Device
Office: Division of Human and Animal Food Operations - West VI
Person: Paul M. Kawamoto (issuing_officer)

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ID · 92483553-8d9d-4e91-b4cf-db00447ee0be