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Evergreen Reporter

Thursday, November 21, 2024

Washington: Device companies were the second most FDA inspected companies in Washington in Q1

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

In the first quarter of 2024, four device companies received four FDA inspections in Washington, according to the U.S. Food and Drug Administration (FDA).

This was the second highest number of inspections per type of company made by the FDA in Washington, equalling 16% of all inspections in the first quarter of 2024.

Of all the Washington companies involved in the device sector, Fluke Biomedical, LLC and Northwest Eye Design, LLC received the most citations from the FDA in the first quarter of 2024.

The FDA routinely inspects facilities across the nation to determine if the workplaces and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly for businesses to consistently make smarter business decisions for the future.

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

FDA Inspections in Washington During Q1
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products2----
Colors and Cosmetics Technology1----
Compliance: Devices13--
Food Composition, Standards, Labeling and Econ5----
Foodborne Biological Hazards731
Human Cellular, Tissue, and Gene Therapies1----
Monitoring of Marketed Animal Drugs, Feed, and Devices1----
Postmarket Assurance: Devices21--
Technical Assistance: Food and Cosmetics51--

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