In the second quarter of 2023, four Biologics companies received four FDA inspections in Connecticut, according to the U.S. Food and Drug Administration (FDA).
This was the highest number of inspections per type of company made by the FDA in Connecticut, equalling 40% of all inspections in the second quarter of 2023.
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 | 2 | — | — |
| Blood and Blood Products | 2 | — | — |
| Compliance: Devices | 2 | — | — |
| Foodborne Biological Hazards | 2 | 1 | — |
| Human Cellular, Tissue, and Gene Therapies | 1 | — | — |
| Postmarket Assurance: Devices | 2 | — | — |
| Vaccines and Allergenic Products | 2 | — | — |
