FDA carried out the second most biologics company inspections in New York in Q1

Sridhar Mantha, Acting Chief Information Officer of FDA
Sridhar Mantha, Acting Chief Information Officer of FDA
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In New York, the FDA conducted inspections at 13 biologics companies during the first quarter of 2026, according to the U.S. Food and Drug Administration (FDA).

These inspections represented the second highest number of FDA visits by company type in New York, accounting for 6.7% of all inspections conducted in the state during the first quarter of 2026.

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.

Top 10 FDA Inspections by Number of Actions Indicated in New York During Q1
Project Area No Action Indicated Voluntary Action Indicated Official Action Indicated
Bioresearch Monitoring 1 1 —
Blood and Blood Products 5 — —
Compliance: Devices 1 3 —
Drug Quality Assurance 3 2 —
Food Composition, Standards, Labeling and Econ 17 11 1
Foodborne Biological Hazards 92 61 2
Human Cellular, Tissue, and Gene Therapies 8 — —
Monitoring of Marketed Animal Drugs, Feed, and Devices 8 1 —
Postmarket Assurance: Devices 3 1 —
Technical Assistance: Food and Cosmetics 2 7 —

Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.



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