In the third quarter of 2025, six Biologics companies received six 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 20% of all inspections in the third 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 and quality.
| Project Area | No Action Indicated | Voluntary Action Indicated | Official Action Indicated |
|---|---|---|---|
| Bioresearch Monitoring | 1 | — | — |
| Blood and Blood Products | 1 | — | — |
| Compliance: Devices | 4 | 5 | — |
| Drug Quality Assurance | 4 | 2 | — |
| Foodborne Biological Hazards | 5 | 1 | — |
| Human Cellular, Tissue, and Gene Therapies | 3 | — | — |
| Postmarket Assurance: Devices | 8 | 1 | — |
| Technical Assistance: Food and Cosmetics | 2 | — | — |
| Vaccines and Allergenic Products | 2 | — | — |
Information in this story was obtained from the U.S. Food and Drug Administration. The source data can be found here.
