During 2025, the FDA inspected 28 biologics companies in Massachusetts, with each company undergoing one inspection, according to the U.S. Food and Drug Administration (FDA).
This total represented the second lowest count of inspections by company type conducted by the FDA in Massachusetts, accounting for 9.4% of all inspections that year.
Among all biologics companies in Massachusetts, Emerson Health Hospital received the highest number of FDA citations in 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 and quality.
| Project Area | No Action Indicated | Voluntary Action Indicated | Official Action Indicated |
|---|---|---|---|
| Bioresearch Monitoring | 23 | 7 | 1 |
| Blood and Blood Products | 8 | 3 | — |
| Compliance: Devices | 15 | 18 | 6 |
| Drug Quality Assurance | 11 | 12 | 1 |
| Food Composition, Standards, Labeling and Econ | 12 | 1 | 1 |
| Foodborne Biological Hazards | 108 | 46 | 1 |
| Human Cellular, Tissue, and Gene Therapies | 11 | — | — |
| Postmarket Assurance: Devices | 28 | 4 | 5 |
| Technical Assistance: Food and Cosmetics | 25 | 3 | — |
| Vaccines and Allergenic Products | 3 | 1 | — |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
