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Wednesday, December 18, 2024

New Jersey: Biologics companies were the second most FDA inspected companies in New Jersey in Q3

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Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

In the third quarter of 2024, eight Biologics companies received eight 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 22.2% of all inspections in the third quarter of 2024.

Of all the New Jersey companies involved in the Biologics sector, North Hudson IVF Center for Fertility & Gynecology, P.C. received the most citations from the FDA in the third quarter of 2024.

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 Q3
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products31--
Drug Quality Assurance231
Food Composition, Standards, Labeling and Econ3----
Foodborne Biological Hazards137--
Human Cellular, Tissue, and Gene Therapies51--
Monitoring of Marketed Animal Drugs, Feed, and Devices2----
Technical Assistance: Food and Cosmetics1----

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