In the first quarter of 2025, two device companies received two FDA inspections in Massachusetts, 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 Massachusetts, equalling 7.4% of all inspections in the first quarter of 2025.
Of all the Massachusetts companies involved in the device sector, Saphena Medical, Inc. received the most citations from the FDA in the first quarter of 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 quality.
| Project Area | No Action Indicated | Voluntary Action Indicated | Official Action Indicated |
|---|---|---|---|
| Blood and Blood Products | 1 | — | — |
| Compliance: Devices | 1 | 1 | — |
| Drug Quality Assurance | — | 2 | — |
| Food Composition, Standards, Labeling and Econ | 4 | 1 | — |
| Foodborne Biological Hazards | 15 | 5 | — |
| Human Cellular, Tissue, and Gene Therapies | 2 | — | — |
| Postmarket Assurance: Devices | 1 | 1 | — |
| Technical Assistance: Food and Cosmetics | 1 | — | — |
