In the fourth quarter of 2024, four Biologics companies received four FDA inspections in New Jersey, according to the U.S. Food and Drug Administration (FDA).
This was the lowest number of inspections per type of company made by the FDA in New Jersey, equalling 8% of all inspections in the fourth quarter of 2024.
Of all the New Jersey companies involved in the Biologics sector, Morristown Medical Center Blood Bank received the most citations from the FDA in the fourth quarter of 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 | 3 | 3 | — |
| Blood and Blood Products | 2 | 1 | — |
| Compliance: Devices | 1 | 2 | 1 |
| Drug Quality Assurance | 2 | 5 | 3 |
| Food Composition, Standards, Labeling and Econ | 5 | 1 | — |
| Foodborne Biological Hazards | 14 | 11 | — |
| Human Cellular, Tissue, and Gene Therapies | 1 | — | — |
| Postmarket Assurance: Devices | 2 | 1 | 1 |
| Radiation Control and Health Safety Act | — | — | 1 |
