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Saturday, November 23, 2024

FDA conducted second lowest number of inspections on Biologics companies in California during Q3 2023

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Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

In the third quarter of 2023, 25 Biologics companies received 25 FDA inspections in California, according to the U.S. Food and Drug Administration (FDA).

This was the second lowest number of inspections per type of company made by the FDA in California, equalling 5.1% of all inspections in the third quarter of 2023.

Of all the California companies involved in the Biologics sector, Tox Laboratory, M.D. received the most citations from the FDA in the third 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 Q3 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring254--
Blood and Blood Products82--
Compliance: Devices1514--
Drug Quality Assurance234
Food Composition, Standards, Labeling and Econ6919--
Foodborne Biological Hazards2381101
Human Cellular, Tissue, and Gene Therapies28--
Monitoring of Marketed Animal Drugs, Feed, and Devices2410--
Postmarket Assurance: Devices186--
Technical Assistance: Food and Cosmetics711--

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