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Sunday, September 29, 2024

FDA conducted second highest number of inspections on Biologics companies in California during August

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Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

In August, 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 11.1% of all inspections in August.

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 August
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products5----
Compliance: Devices21--
Food Composition, Standards, Labeling and Econ93--
Foodborne Biological Hazards1913--
Human Cellular, Tissue, and Gene Therapies1----
Monitoring of Marketed Animal Drugs, Feed, and Devices5----
Postmarket Assurance: Devices3----
Technical Assistance: Food and Cosmetics2----

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