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Saturday, December 21, 2024

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

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James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

In July, 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 15.4% of all inspections in July.

Of all the New York companies involved in Biologics, Mount Sinai Hospital Blood Bank received the most citations from the FDA in July.

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 July
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products11--
Drug Quality Assurance--1--
Food Composition, Standards, Labeling and Econ21--
Foodborne Biological Hazards72--

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