In the first quarter of 2024, two Biologics companies received two FDA inspections in Missouri, 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 Missouri, equalling 4% of all inspections in the first quarter of 2024.
Of all the Missouri companies involved in the Biologics sector, Center for Reproductive Medicine & Robotic Surgery, 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 |
|---|---|---|---|
| Blood and Blood Products | 1 | 1 | — |
| Compliance: Devices | 2 | 2 | — |
| Drug Quality Assurance | 1 | 2 | — |
| Food Composition, Standards, Labeling and Econ | 3 | — | — |
| Food and Color Additives Petition Review | 2 | — | — |
| Foodborne Biological Hazards | 27 | 3 | — |
| Human Cellular, Tissue, and Gene Therapies | 1 | 1 | — |
| Monitoring of Marketed Animal Drugs, Feed, and Devices | 7 | — | — |
| Postmarket Assurance: Devices | 4 | — | — |
| Technical Assistance: Food and Cosmetics | 4 | — | — |
