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This document outlines the FDA\'s inspection observations for Cleveland Diagnostics, Inc. regarding process validation, risk analysis, and design validation failures, issued on November 10, 2021.
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What is form fda-483?
Form FDA-483 is a document issued by the U.S. Food and Drug Administration (FDA) to notify a company that an inspection has found conditions that may violate the Federal Food, Drug, and Cosmetic Act.
Who is required to file form fda-483?
Form FDA-483 is typically issued to manufacturers, processors, or importers of food, drugs, devices, cosmetics, and biological products that are subject to FDA regulations.
How to fill out form fda-483?
Form FDA-483 should be filled out by FDA inspectors during an inspection, detailing any observed conditions of non-compliance. Companies do not fill out this form themselves.
What is the purpose of form fda-483?
The purpose of Form FDA-483 is to communicate to the inspected entity any observed violations or concerns that may require corrective action.
What information must be reported on form fda-483?
Form FDA-483 must report specific observations of non-compliance related to FDA regulations during inspections, including details about the nature of the violations.
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