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Monday, April 29, 2024

New York: Biologics companies were the second most FDA inspected companies in New York in February

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Vid Desai FDA’s Chief Information Officer | Official Website

Vid Desai FDA’s Chief Information Officer | Official Website

In February, four Biologics companies received four FDA inspections in New York, according to the U.S. Food and Drug Administration (FDA).

This was the second highest number of inspections per type of company made by the FDA in New York, equalling 30.8% of all inspections in February.

Of all the New York companies involved in Biologics, RMA Long Island IVF and New Hope Fertility Center received the most citations from the FDA in February.

The FDA routinely inspects facilities across the nation to determine if the workplaces and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly for businesses to consistently make smarter business decisions for the future.

The FDA is a government agency primarily responsible for monitoring the manufacturing and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

FDA inspections in New York during February
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products4----
Compliance: Devices--2--
Drug Quality Assurance--1--
Foodborne Biological Hazards51--
Human Cellular, Tissue, and Gene Therapies12--
Postmarket Assurance: Devices1----

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