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Sunshine Sentinel

Wednesday, November 20, 2024

FDA conducted third highest number of inspections on device companies in Florida during Q3

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Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

In the third quarter of 2024, four device companies received four FDA inspections in Florida, according to the U.S. Food and Drug Administration (FDA).

This was the third highest number of inspections per type of company made by the FDA in Florida, equalling 6.2% of all inspections in the third quarter of 2024.

Of all the Florida companies involved in the device sector, Excite Medical of Tampa Bay, LLC 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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