In the first quarter of 2024, five device companies received five FDA inspections in Massachusetts, according to the U.S. Food and Drug Administration (FDA).
This was the second highest number of inspections per type of company made by the FDA in Massachusetts, equalling 21.7% of all inspections in the first quarter of 2024.
Of all the Massachusetts companies involved in the device sector, Med Pen Concepts, LLC received the most citations from the FDA in the first quarter of 2024.
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 | — | — |
| Compliance: Devices | 1 | 2 | 1 |
| Drug Quality Assurance | — | 1 | — |
| Foodborne Biological Hazards | 8 | 6 | 1 |
| Monitoring of Marketed Animal Drugs, Feed, and Devices | 1 | — | — |
| Postmarket Assurance: Devices | 1 | — | — |
