Immunexpress, Inc. in Seattle scheduled for FDA inspection on Dec. 6, 2024

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA
Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA - Official Website
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The Food and Drug Administration (FDA) inspected Immunexpress, Inc. in Seattle on December 6, 2024, as part of its post-market assurance activities for medical devices. During the inspection, the company was issued a single citation, according to data posted on the FDA’s website.

The FDA website shows that the company was cited for the following problem: ‘Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.’

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety and quality.

Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.



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