During 2025, the FDA inspected 16 biologics companies across Oregon, conducting one inspection per company, according to the U.S. Food and Drug Administration (FDA).
This inspection count represented the third highest among company types in Oregon and accounted for 5.7% of all FDA inspections in the state that year.
Among Oregon’s biologics companies, Asante Health System IRB received the largest number of citations from the FDA 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.
| Project Area | No Action Indicated | Voluntary Action Indicated | Official Action Indicated |
|---|---|---|---|
| Bioresearch Monitoring | 8 | 4 | — |
| Blood and Blood Products | 5 | — | — |
| Colors and Cosmetics Technology | 2 | — | — |
| Compliance: Devices | — | 1 | — |
| Drug Quality Assurance | — | 2 | 1 |
| Food Composition, Standards, Labeling and Econ | 21 | 6 | — |
| Foodborne Biological Hazards | 198 | 24 | 1 |
| Human Cellular, Tissue, and Gene Therapies | 9 | — | — |
| Monitoring of Marketed Animal Drugs, Feed, and Devices | 13 | 3 | 1 |
| Technical Assistance: Food and Cosmetics | 7 | 1 | — |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
