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Thursday, November 7, 2024

FDA conducted second highest number of inspections on Biologics companies in Florida during Q2 2023

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Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

In the second quarter of 2023, 43 Biologics companies received 43 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 22.2% of all inspections in the second quarter of 2023.

Of all the Florida companies involved in the Biologics sector, Kedplasma, LLC, Maria I. Bermudez, M.D., and Beth E. Safirstein, M.D., tied with one other company, equally received the highest number of citations from the FDA in the second 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 Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring82--
Blood and Blood Products332--
Compliance: Devices916--
Drug Quality Assurance131
Food Composition, Standards, Labeling and Econ2412--
Foodborne Biological Hazards61191
Human Cellular, Tissue, and Gene Therapies8----
Postmarket Assurance: Devices177--
Technical Assistance: Food and Cosmetics18----
Vaccines and Allergenic Products6----

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