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Wednesday, December 18, 2024

FDA conducted lowest number of inspections on device companies in Colorado during Q3

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Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

In the third quarter of 2024, two device companies received two FDA inspections in Colorado, according to the U.S. Food and Drug Administration (FDA).

This was the lowest number of inspections per type of company made by the FDA in Colorado, equalling 11.1% of all inspections in the third quarter of 2024.

Of all the Colorado companies involved in the device sector, Newman Medical received the most citations from the FDA in the third 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 Colorado During Q3
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products4----
Compliance: Devices--2--
Food Composition, Standards, Labeling and Econ22--
Foodborne Biological Hazards63--
Human Cellular, Tissue, and Gene Therapies1----
Monitoring of Marketed Animal Drugs, Feed, and Devices2----
Postmarket Assurance: Devices11--
Technical Assistance: Food and Cosmetics1----

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