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Monday, December 23, 2024

FDA conducted second highest number of inspections on device companies in California during Q2

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Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

In the second quarter of 2024, 13 device companies received 13 FDA inspections in California, 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 California, equalling 7.6% of all inspections in the second quarter of 2024.

Of all the California companies involved in the device sector, Evoqua Water Technologies, LLC received the most citations from the FDA in the second 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 Q2
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products7----
Compliance: Devices85--
Drug Quality Assurance--2--
Food Composition, Standards, Labeling and Econ279--
Foodborne Biological Hazards8540--
Human Cellular, Tissue, and Gene Therapies1----
Monitoring of Marketed Animal Drugs, Feed, and Devices92--
Postmarket Assurance: Devices10----
Technical Assistance: Food and Cosmetics41--
Tobacco Post-Market Activities11--

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