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Great Lakes Wire

Tuesday, April 22, 2025

Michigan: Device companies were the third least FDA inspected companies in Michigan in 2024

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Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

In 2024, 12 device companies received 12 FDA inspections in Michigan, 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 Michigan, equalling 9% of all inspections in 2024.

Of all the Michigan companies involved in the device sector, Danmar Products, Inc. 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 Michigan During 2024
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring12
Blood and Blood Products112
Compliance: Devices281
Drug Quality Assurance131
Food Composition, Standards, Labeling and Econ63
Foodborne Biological Hazards49212
Human Cellular, Tissue, and Gene Therapies4
Monitoring of Marketed Animal Drugs, Feed, and Devices1052
Postmarket Assurance: Devices9
Technical Assistance: Food and Cosmetics101

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