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Sunday, November 24, 2024

New Jersey: Biologics companies were the second most FDA inspected companies in New Jersey in Q4 2023

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

In the fourth quarter of 2023, seven Biologics companies received seven FDA inspections in New Jersey, 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 New Jersey, equalling 12.1% of all inspections in the fourth quarter of 2023.

Of all the New Jersey companies involved in the Biologics sector, Newark Beth Israel Medical Center - Blood Bank 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.

FDA Inspections in New Jersey During Q4 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products51--
Drug Quality Assurance--3--
Food Composition, Standards, Labeling and Econ10----
Foodborne Biological Hazards3313--
Human Cellular, Tissue, and Gene Therapies2----
Monitoring of Marketed Animal Drugs, Feed, and Devices1----
Tobacco Post-Market Activities1----

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