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Thursday, November 21, 2024

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

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

In September, three Biologics companies received three 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 8.8% of all inspections in September.

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 September
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products1----
Compliance: Devices11--
Drug Quality Assurance1----
Food Composition, Standards, Labeling and Econ42--
Foodborne Biological Hazards196--
Human Cellular, Tissue, and Gene Therapies2----
Monitoring of Marketed Animal Drugs, Feed, and Devices3----
Postmarket Assurance: Devices1----
Technical Assistance: Food and Cosmetics1----

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