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Saturday, November 2, 2024

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

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Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

In the second quarter of 2023, four Biologics 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 6.3% of all inspections in the second quarter of 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 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.

FDA Inspections in Arizona During Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring31--
Blood and Blood Products--1--
Compliance: Devices--1--
Food Composition, Standards, Labeling and Econ111
Foodborne Biological Hazards469--
Human Cellular, Tissue, and Gene Therapies--1--
Monitoring of Marketed Animal Drugs, Feed, and Devices1----
Postmarket Assurance: Devices1----
Technical Assistance: Food and Cosmetics2----

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