Two medical device companies in Indiana underwent FDA inspections during March, according to the U.S. Food and Drug Administration (FDA).
These inspections represented the third highest count for any company category in Indiana, accounting for 16.7% of all FDA inspections conducted in the state that month.
Among Indiana’s medical device firms, Analytical Control Systems, Inc. received the largest number of FDA citations in March.
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 |
|---|---|---|---|
| Blood and Blood Products | 2 | — | — |
| Compliance: Devices | — | 2 | — |
| Drug Quality Assurance | 1 | — | — |
| Food Composition, Standards, Labeling and Econ | 2 | — | — |
| Foodborne Biological Hazards | 4 | — | — |
| Monitoring of Marketed Animal Drugs, Feed, and Devices | 3 | — | — |
