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Friday, May 3, 2024

Arizona: Biologics companies were the second most FDA inspected companies in Arizona in 2023

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Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

In 2023, 13 Biologics companies received 15 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 7.1% of all inspections in 2023.

Of all the Arizona companies involved in the Biologics sector, Arizona Center for Reproductive Endocrinology & Infertility received the most citations from the FDA in 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 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring82--
Blood and Blood Products82--
Compliance: Devices96--
Drug Quality Assurance--32
Food Composition, Standards, Labeling and Econ451
Foodborne Biological Hazards129241
Human Cellular, Tissue, and Gene Therapies22--
Monitoring of Marketed Animal Drugs, Feed, and Devices81--
Postmarket Assurance: Devices15----
Technical Assistance: Food and Cosmetics41--

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