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Sunshine Sentinel

Tuesday, November 5, 2024

Florida: Biologics companies were the second most FDA inspected companies in Florida in Q2

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Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

In the second quarter of 2024, 10 Biologics companies received 10 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 20.4% of all inspections in the second quarter of 2024.

Of all the Florida companies involved in the Biologics sector, North Florida Reproductive Biology Laboratory received the most citations from the FDA in the second 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.

FDA Inspections in Florida During Q2
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products10----
Compliance: Devices37--
Drug Quality Assurance11--
Food Composition, Standards, Labeling and Econ52--
Foodborne Biological Hazards142--
Human Cellular, Tissue, and Gene Therapies11--
Monitoring of Marketed Animal Drugs, Feed, and Devices--2--
Postmarket Assurance: Devices45--
Technical Assistance: Food and Cosmetics6----

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