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Thursday, November 7, 2024

FDA conducted third highest number of inspections on device companies in Florida during Q1 2023

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Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

In the first 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 third highest number of inspections per type of company made by the FDA in Florida, equalling 15.9% of all inspections in the first quarter of 2023.

Of all the Florida companies involved in the device sector, Best Image Optical, Inc. received the most citations from the FDA in the first 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 Q1 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring13121
Blood and Blood Products263--
Compliance: Devices1216--
Drug Quality Assurance113
Food Composition, Standards, Labeling and Econ1843
Foodborne Biological Hazards4923--
Human Cellular, Tissue, and Gene Therapies173--
Postmarket Assurance: Devices187--
Technical Assistance: Food and Cosmetics16----
Vaccines and Allergenic Products362--

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