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Tuesday, May 14, 2024

FDA conducted second lowest number of inspections on device companies in Washington during 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, seven device companies received seven FDA inspections in Washington, according to the U.S. Food and Drug Administration (FDA).

This was the second lowest number of inspections per type of company made by the FDA in Washington, equalling 3.2% of all inspections in 2023.

Of all the Washington companies involved in the device sector, CurvaFix, Inc. 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 Washington During 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring6----
Blood and Blood Products132--
Compliance: Devices25--
Food Composition, Standards, Labeling and Econ218--
Foodborne Biological Hazards8433--
Human Cellular, Tissue, and Gene Therapies7----
Monitoring of Marketed Animal Drugs, Feed, and Devices112--
Postmarket Assurance: Devices43--
Technical Assistance: Food and Cosmetics5312--
Vaccines and Allergenic Products7----

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