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Sunday, May 19, 2024

Florida: Biologics companies were the third most FDA inspected companies in Florida in Q4 2023

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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 fourth quarter of 2023, 19 Biologics companies received 19 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 14.6% of all inspections in the fourth quarter of 2023.

Of all the Florida companies involved in the Biologics sector, Fertility Center of Orlando received the most citations from the FDA in the fourth quarter of 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 Q4 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring3----
Blood and Blood Products143--
Compliance: Devices1613--
Drug Quality Assurance131
Food Composition, Standards, Labeling and Econ147--
Foodborne Biological Hazards3914--
Human Cellular, Tissue, and Gene Therapies32--
Monitoring of Marketed Animal Drugs, Feed, and Devices3----
Postmarket Assurance: Devices159--
Technical Assistance: Food and Cosmetics11----

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