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Thursday, November 21, 2024

Arizona: Device companies were the second most FDA inspected companies in Arizona in Q1 2023

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

In the first quarter of 2023, four device companies received four FDA inspections in Arizona, 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 Arizona, equalling 8% of all inspections in the first quarter of 2023.

Of all the Arizona companies involved in the device sector, DentiMax, Inc. and Promedtek, 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 Arizona During Q1 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring11--
Blood and Blood Products11--
Compliance: Devices13--
Drug Quality Assurance--1--
Food Composition, Standards, Labeling and Econ11--
Foodborne Biological Hazards298--
Human Cellular, Tissue, and Gene Therapies--1--
Monitoring of Marketed Animal Drugs, Feed, and Devices11--
Postmarket Assurance: Devices4----
Technical Assistance: Food and Cosmetics21--

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