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Saturday, January 18, 2025

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

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James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

In December 2023, three Biologics companies received three 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 14.3% of all inspections in December 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 December 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products2----
Drug Quality Assurance--1--
Food Composition, Standards, Labeling and Econ7----
Foodborne Biological Hazards125--
Human Cellular, Tissue, and Gene Therapies1----

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