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Saturday, November 2, 2024

California: Biologics companies were the second most FDA inspected companies in California in December 2023

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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 December 2023, 10 Biologics companies received 10 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 13.9% of all inspections in December 2023.

Of all the California companies involved in Biologics, Southern California Center for Reproductive Medicine received the most citations from the FDA in December 2023.

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 December 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products71--
Compliance: Devices24--
Drug Quality Assurance--5--
Food Composition, Standards, Labeling and Econ62--
Foodborne Biological Hazards2717--
Human Cellular, Tissue, and Gene Therapies52--
Monitoring of Marketed Animal Drugs, Feed, and Devices41--
Postmarket Assurance: Devices6----

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