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Thursday, October 31, 2024

California: Biologics companies were the second most FDA inspected companies in California in Q3

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

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

In the third quarter of 2024, 18 Biologics companies received 18 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 9.4% of all inspections in the third quarter of 2024.

Of all the California companies involved in the Biologics sector, Williams OB/GYN & Associates 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----

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