In the second quarter of 2025, two device companies received two FDA inspections in Colorado, according to the U.S. Food and Drug Administration (FDA).
This was the third highest number of inspections per type of company made by the FDA in Colorado, equalling 8.7% of all inspections in the second quarter of 2025.
Of all the Colorado companies involved in the device sector, Paragon 28, Inc. and Mighty Oak Medical received the most citations from the FDA in the second quarter of 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 quality.
| Project Area | No Action Indicated | Voluntary Action Indicated | Official Action Indicated |
|---|---|---|---|
| Bioresearch Monitoring | — | — | 1 |
| Compliance: Devices | — | 1 | — |
| Drug Quality Assurance | 1 | — | — |
| Food Composition, Standards, Labeling and Econ | 2 | 3 | — |
| Foodborne Biological Hazards | 7 | 4 | — |
| Human Cellular, Tissue, and Gene Therapies | 5 | — | — |
| Monitoring of Marketed Animal Drugs, Feed, and Devices | 2 | — | — |
| Pesticides and Chemical Contaminants | 1 | — | — |
| Postmarket Assurance: Devices | 1 | — | — |
