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Tuesday, April 22, 2025

New Jersey: Device companies were the third least FDA inspected companies in New Jersey in 2024

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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 2024, 19 device companies received 19 FDA inspections in New Jersey, 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 New Jersey, equalling 6.4% of all inspections in 2024.

Of all the New Jersey companies involved in the device sector, Trutek, Corp. received the most citations from the FDA in 2024.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality.

Top 10 FDA Inspections by Number of Actions Indicated in New Jersey During 2024
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1610
Blood and Blood Products102
Compliance: Devices773
Drug Quality Assurance11168
Food Composition, Standards, Labeling and Econ3961
Foodborne Biological Hazards134522
Human Cellular, Tissue, and Gene Therapies122
Monitoring of Marketed Animal Drugs, Feed, and Devices31
Postmarket Assurance: Devices931
Technical Assistance: Food and Cosmetics31

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