Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
This was the second highest number of inspections per type of company made by the FDA in Colorado, equalling 21.4% of all inspections in the second quarter of 2023.
Of all the Colorado companies involved in the device sector, CoRE labs, LLC and Allison Medical, Inc. received the most citations from the FDA in the second quarter of 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 | 1 | -- |
| Blood and Blood Products | 3 | 1 | -- |
| Compliance: Devices | -- | 4 | -- |
| Foodborne Biological Hazards | 15 | 4 | -- |
| Monitoring of Marketed Animal Drugs, Feed, and Devices | 7 | 1 | -- |
| Postmarket Assurance: Devices | 2 | 1 | -- |
| Technical Assistance: Food and Cosmetics | 3 | -- | -- |
| Vaccines and Allergenic Products | 1 | -- | -- |
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