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Wednesday, December 25, 2024

FDA conducted third lowest number of inspections on Biologics companies in California during Q2 2023

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Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

In the second quarter of 2023, 28 Biologics companies received 28 FDA inspections in California, according to the U.S. Food and Drug Administration (FDA).

This was the third lowest number of inspections per type of company made by the FDA in California, equalling 4.5% of all inspections in the second quarter of 2023.

Of all the California companies involved in the Biologics sector, Incinta Fertility Center, LLC received the most citations from the FDA in the second 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 Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring161--
Blood and Blood Products183--
Compliance: Devices14114
Drug Quality Assurance--62
Food Composition, Standards, Labeling and Econ71215
Foodborne Biological Hazards3501285
Human Cellular, Tissue, and Gene Therapies126--
Monitoring of Marketed Animal Drugs, Feed, and Devices3212--
Postmarket Assurance: Devices1811
Tobacco Post-Market Activities311

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