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Sunday, November 24, 2024

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

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Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

In June, two Biologics companies received two 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 20% of all inspections in June.

Of all the New York companies involved in Biologics, California Cryobank, LLC received the most citations from the FDA in June.

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 June
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Compliance: Devices1----
Foodborne Biological Hazards52--
Human Cellular, Tissue, and Gene Therapies11--
Postmarket Assurance: Devices1----
Technical Assistance: Food and Cosmetics22--

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