FDA conducted third highest number of inspections on Biologics companies in Florida during 2023

FDA conducted third highest number of inspections on Biologics companies in Florida during 2023
Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA — Official Website
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In 2023, 115 Biologics companies received 115 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 16.1% of all inspections in 2023.

Of all the Florida companies involved in the Biologics sector, Florida Fertility Institute, P. A. received the most citations from the FDA in 2023.

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 2023
Project Area No Action Indicated Voluntary Action Indicated Official Action Indicated
Bioresearch Monitoring 42 16 1
Blood and Blood Products 81 8
Compliance: Devices 52 56
Food Composition, Standards, Labeling and Econ 80 37 4
Foodborne Biological Hazards 198 84 3
Human Cellular, Tissue, and Gene Therapies 30 5
Monitoring of Marketed Animal Drugs, Feed, and Devices 17 16 2
Postmarket Assurance: Devices 68 29
Technical Assistance: Food and Cosmetics 64 2
Vaccines and Allergenic Products 42 2


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