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Sunday, May 5, 2024

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

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Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

In January, 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 14.3% of all inspections in January.

Of all the New York companies involved in Biologics, Generation Next Fertility received the most citations from the FDA in January.

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.

Top 10 FDA inspections by Number of Actions Indicated in New York during January
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products22--
Compliance: Devices11--
Drug Quality Assurance--1--
Food Composition, Standards, Labeling and Econ12--
Foodborne Biological Hazards88--
Human Cellular, Tissue, and Gene Therapies11--
Monitoring of Marketed Animal Drugs, Feed, and Devices11--
Postmarket Assurance: Devices2----
Technical Assistance: Food and Cosmetics--1--

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