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Monday, December 23, 2024

Florida: Device companies were the second most FDA inspected companies in Florida in Q3 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 third quarter of 2023, 31 device companies received 31 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 16% of all inspections in the third quarter of 2023.

Of all the Florida companies involved in the device sector, Precision Align, LLC and Ultra Clean Systems, Inc. received the most citations from the FDA in the third 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 Q3 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring152--
Blood and Blood Products10----
Compliance: Devices1411--
Drug Quality Assurance233
Food Composition, Standards, Labeling and Econ24141
Foodborne Biological Hazards50262
Human Cellular, Tissue, and Gene Therapies2----
Monitoring of Marketed Animal Drugs, Feed, and Devices12111
Postmarket Assurance: Devices186--
Technical Assistance: Food and Cosmetics192--

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