Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This was the second highest number of inspections per type of company made by the FDA in North Carolina, equalling 20% of all inspections in the first quarter of 2024.
Of all the North Carolina companies involved in the Biologics sector, Cone Health received the most citations from the FDA in the first quarter of 2024.
The FDA routinely inspects facilities across the nation to determine if the workplaces and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly for businesses to consistently make smarter business decisions for the future.
The FDA is a government agency primarily responsible for monitoring the manufacturing and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.
| Project Area | No Action Indicated | Voluntary Action Indicated | Official Action Indicated |
|---|---|---|---|
| Bioresearch Monitoring | 1 | -- | -- |
| Blood and Blood Products | 3 | 1 | -- |
| Compliance: Devices | 2 | 1 | -- |
| Drug Quality Assurance | 1 | 1 | 1 |
| Food Composition, Standards, Labeling and Econ | 1 | 1 | -- |
| Foodborne Biological Hazards | 5 | 2 | -- |
| Human Cellular, Tissue, and Gene Therapies | 1 | -- | -- |
| Postmarket Assurance: Devices | 1 | -- | -- |
| Technical Assistance: Food and Cosmetics | 2 | -- | -- |
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