The FDA conducted 32 inspections across 32 biologics companies in New York during 2025, according to the U.S. Food and Drug Administration (FDA).
This figure represented the second lowest number of inspections by company type performed by the FDA in New York, accounting for 3.9% of all inspections that year.
Among biologics companies in New York, NYU Langone Health Hospital received the highest number of FDA citations 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 | 43 | 7 | — |
| Blood and Blood Products | 4 | 7 | — |
| Compliance: Devices | 17 | 31 | 1 |
| Drug Quality Assurance | 14 | 30 | 5 |
| Food Composition, Standards, Labeling and Econ | 29 | 21 | — |
| Foodborne Biological Hazards | 361 | 175 | 9 |
| Human Cellular, Tissue, and Gene Therapies | 16 | 2 | — |
| Monitoring of Marketed Animal Drugs, Feed, and Devices | 30 | 11 | 1 |
| Postmarket Assurance: Devices | 37 | 10 | — |
| Technical Assistance: Food and Cosmetics | 40 | 21 | — |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
