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Saturday, December 21, 2024

FDA conducted third highest number of inspections on device companies in California during Q3

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

In the third quarter of 2024, 16 device companies received 16 FDA inspections in California, according to the U.S. Food and Drug Administration (FDA).

This was the third highest number of inspections per type of company made by the FDA in California, equalling 8.4% of all inspections in the third quarter of 2024.

Of all the California companies involved in the device sector, Imedrix, Inc. 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.

Top 10 FDA Inspections by Number of Actions Indicated in California During Q3
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products101--
Colors and Cosmetics Technology22--
Compliance: Devices79--
Drug Quality Assurance31--
Food Composition, Standards, Labeling and Econ2514--
Foodborne Biological Hazards9039--
Human Cellular, Tissue, and Gene Therapies64--
Monitoring of Marketed Animal Drugs, Feed, and Devices151--
Postmarket Assurance: Devices13----
Technical Assistance: Food and Cosmetics8----