James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This was the lowest number of inspections per type of company made by the FDA in Massachusetts, equalling 16.7% of all inspections in November 2024.
Of all the Massachusetts companies involved in Drugs, Alexion Pharmaceuticals, Inc. received the most citations from the FDA in November 2024.
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 |
|---|---|---|---|
| Bioresearch Monitoring | — | 1 | — |
| Compliance: Devices | 1 | 2 | — |
| Drug Quality Assurance | — | 1 | — |
| Foodborne Biological Hazards | 6 | 1 | — |
| Postmarket Assurance: Devices | 2 | — | — |
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