Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
This was the third lowest number of inspections per type of company made by the FDA in Minnesota, equalling 2.8% of all inspections in 2023.
Of all the Minnesota companies involved in the Drugs sector, ProMed Pharma, LLC and Children's Healthcare IRB #1 received the most citations from the FDA in 2023.
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 | 5 | 3 | -- |
| Blood and Blood Products | 5 | -- | -- |
| Compliance: Devices | 17 | 10 | 2 |
| Drug Quality Assurance | 1 | 3 | 1 |
| Food Composition, Standards, Labeling and Econ | 7 | 4 | -- |
| Foodborne Biological Hazards | 103 | 36 | 2 |
| Human Cellular, Tissue, and Gene Therapies | 3 | -- | -- |
| Monitoring of Marketed Animal Drugs, Feed, and Devices | 19 | 12 | 2 |
| Postmarket Assurance: Devices | 13 | 4 | -- |
| Technical Assistance: Food and Cosmetics | 58 | 1 | -- |
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