Device companies ranked third for FDA inspections in New Jersey in 2025

Grace Graham, Deputy Commissioner for Policy, Legislation, and International Affairs of FDA
Grace Graham, Deputy Commissioner for Policy, Legislation, and International Affairs of FDA
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The FDA conducted a total of 56 inspections at 56 different device companies within New Jersey during 2025, according to the U.S. Food and Drug Administration (FDA).

This figure represented the third highest number of inspections by company type in New Jersey, accounting for 10.2% of all FDA inspections conducted in the state that year.

Among New Jersey’s device companies, Keystone Industries and Physitemp Instruments, LLC received the largest number of FDA citations in 2025.

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 and quality.

Top 10 FDA Inspections by Number of Actions Indicated in New Jersey During 2025
Project Area No Action Indicated Voluntary Action Indicated Official Action Indicated
Bioresearch Monitoring 33 11 2
Blood and Blood Products 14 — —
Compliance: Devices 16 30 4
Drug Quality Assurance 28 34 6
Food Composition, Standards, Labeling and Econ 71 8 —
Foodborne Biological Hazards 238 79 4
Human Cellular, Tissue, and Gene Therapies 8 2 —
Monitoring of Marketed Animal Drugs, Feed, and Devices 9 3 1
Postmarket Assurance: Devices 35 7 3
Technical Assistance: Food and Cosmetics 14 3 —

Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.



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