The FDA conducted 31 inspections across 31 biologics firms in Indiana during 2025, according to the U.S. Food and Drug Administration (FDA).
These inspections represented the third highest count among company types inspected by the FDA in Indiana, accounting for 12% of all inspections conducted that year.
Among the biologics companies in Indiana, Indiana Coast Medical, LLC received the greatest number of citations from the FDA in 2025.
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 and quality.
| Project Area | No Action Indicated | Voluntary Action Indicated | Official Action Indicated |
|---|---|---|---|
| Bioresearch Monitoring | 12 | 7 | — |
| Blood and Blood Products | 9 | 2 | — |
| Compliance: Devices | 5 | 7 | 1 |
| Drug Quality Assurance | 3 | 11 | 2 |
| Food Composition, Standards, Labeling and Econ | 24 | 3 | — |
| Foodborne Biological Hazards | 105 | 20 | 1 |
| Human Cellular, Tissue, and Gene Therapies | 12 | 3 | — |
| Monitoring of Marketed Animal Drugs, Feed, and Devices | 28 | 18 | 2 |
| Postmarket Assurance: Devices | 7 | — | — |
| Technical Assistance: Food and Cosmetics | 9 | 1 | — |
