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Monday, December 23, 2024

California: Device companies were the third least FDA inspected companies in California in Q1

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

In the first quarter of 2024, 16 device companies received 17 FDA inspections in California, according to the U.S. Food and Drug Administration (FDA).

This was the third lowest number of inspections per type of company made by the FDA in California, equalling 8.4% of all inspections in the first quarter of 2024.

Of all the California companies involved in the device sector, Amrex Zetron, Inc. received the most citations from the FDA in the first quarter of 2024.

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 California During Q1
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring--2--
Blood and Blood Products131--
Compliance: Devices97--
Drug Quality Assurance14--
Food Composition, Standards, Labeling and Econ2110--
Foodborne Biological Hazards10436--
Human Cellular, Tissue, and Gene Therapies5----
Monitoring of Marketed Animal Drugs, Feed, and Devices162--
Postmarket Assurance: Devices82--
Technical Assistance: Food and Cosmetics6----

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