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Thursday, November 14, 2024

Florida: Biologics companies were the second most FDA inspected companies in Florida in Q3

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

In the third quarter of 2024, 15 Biologics companies received 15 FDA inspections in Florida, 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 Florida, equalling 23.1% of all inspections in the third quarter of 2024.

Of all the Florida companies involved in the Biologics sector, Specialists in Reproductive Medicine & Surgery, P. A. received the most citations from the FDA in the third quarter of 2024.

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 Florida During Q3
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products9----
Compliance: Devices22--
Drug Quality Assurance--2--
Food Composition, Standards, Labeling and Econ36--
Foodborne Biological Hazards1881
Human Cellular, Tissue, and Gene Therapies61--
Monitoring of Marketed Animal Drugs, Feed, and Devices11--
Postmarket Assurance: Devices3----
Technical Assistance: Food and Cosmetics91--
Tobacco Post-Market Activities1----

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