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Tuesday, April 22, 2025

FDA conducted third highest number of inspections on device companies in California during 2024

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Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

In 2024, 107 device companies received 109 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 7.2% of all inspections in 2024.

Of all the California companies involved in the device sector, OrthoGroup, Inc. received the most citations from the FDA in 2024.

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 quality.

Top 10 FDA Inspections by Number of Actions Indicated in California During 2024
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring3211
Blood and Blood Products608
Compliance: Devices47502
Drug Quality Assurance6236
Food Composition, Standards, Labeling and Econ182756
Foodborne Biological Hazards75228825
Human Cellular, Tissue, and Gene Therapies23121
Monitoring of Marketed Animal Drugs, Feed, and Devices93161
Postmarket Assurance: Devices697
Technical Assistance: Food and Cosmetics277

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