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Golden State Today

Tuesday, December 24, 2024

California: Biologics companies were the third most FDA inspected companies in California in Q4 2023

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Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

In the fourth quarter of 2023, 19 Biologics companies received 19 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 6.4% of all inspections in the fourth quarter of 2023.

Of all the California companies involved in the Biologics sector, C. A. R. E. Fertility received the most citations from the FDA in the fourth quarter of 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.

Top 10 FDA Inspections by Number of Actions Indicated in California During Q4 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring51--
Blood and Blood Products114--
Compliance: Devices881
Drug Quality Assurance--104
Food Composition, Standards, Labeling and Econ39111
Foodborne Biological Hazards131791
Human Cellular, Tissue, and Gene Therapies95--
Monitoring of Marketed Animal Drugs, Feed, and Devices1721
Postmarket Assurance: Devices13----
Technical Assistance: Food and Cosmetics43--