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Saturday, November 2, 2024

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

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Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

In January, five Biologics companies received five 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 10.2% of all inspections in January.

Of all the California companies involved in Biologics, Children's Hospital of Orange County received the most citations from the FDA in January.

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 California during January
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products21--
Compliance: Devices3----
Food Composition, Standards, Labeling and Econ83--
Foodborne Biological Hazards306--
Human Cellular, Tissue, and Gene Therapies2----
Monitoring of Marketed Animal Drugs, Feed, and Devices31--
Postmarket Assurance: Devices3----
Technical Assistance: Food and Cosmetics1----
Tobacco Post-Market Activities1----

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