In 2024, 48 Biologics companies received 49 FDA inspections in North Carolina, according to the U.S. Food and Drug Administration (FDA).
This was the second highest number of inspections per type of company made by the FDA in North Carolina, equalling 24.5% of all inspections in 2024.
Of all the North Carolina companies involved in the Biologics sector, Indivior Manufacturing, LLC 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.
| Project Area | No Action Indicated | Voluntary Action Indicated | Official Action Indicated |
|---|---|---|---|
| Bioresearch Monitoring | 30 | 3 | — |
| Blood and Blood Products | 24 | 6 | — |
| Compliance: Devices | 6 | 11 | 1 |
| Drug Quality Assurance | 1 | 5 | 2 |
| Food Composition, Standards, Labeling and Econ | 19 | 5 | — |
| Foodborne Biological Hazards | 55 | 22 | 1 |
| Human Cellular, Tissue, and Gene Therapies | 15 | 2 | — |
| Monitoring of Marketed Animal Drugs, Feed, and Devices | 3 | — | 1 |
| Postmarket Assurance: Devices | 11 | 2 | — |
| Technical Assistance: Food and Cosmetics | 9 | 3 | — |
