FDA conducted lowest number of inspections on Biologics companies in New York during Q1

FDA conducted lowest number of inspections on Biologics companies in New York during Q1
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration — Official Website
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In the first quarter of 2025, one Biologics company received an FDA inspection in New York, 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 New York, equalling 1.4% of all inspections in the first quarter of 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 quality.

FDA Inspections in New York During Q1
Project Area No Action Indicated Voluntary Action Indicated Official Action Indicated
Compliance: Devices 2 6
Drug Quality Assurance 2 3
Food Composition, Standards, Labeling and Econ 3
Foodborne Biological Hazards 30 19
Human Cellular, Tissue, and Gene Therapies 1
Monitoring of Marketed Animal Drugs, Feed, and Devices 3 1
Postmarket Assurance: Devices 7 1
Radiation Control and Health Safety Act 1
Technical Assistance: Food and Cosmetics 4


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