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Tuesday, November 26, 2024

FDA conducted second highest number of inspections on device companies in Oregon during Q2 2023

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Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

In the second quarter of 2023, two device companies received two FDA inspections in Oregon, 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 Oregon, equalling 5.6% of all inspections in the second quarter of 2023.

Of all the Oregon companies involved in the device sector, Parks Medical Electronics, Inc. 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 Oregon During Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Colors and Cosmetics Technology1----
Compliance: Devices--11
Food Composition, Standards, Labeling and Econ84--
Foodborne Biological Hazards222--
Monitoring of Marketed Animal Drugs, Feed, and Devices1----
Postmarket Assurance: Devices2----
Technical Assistance: Food and Cosmetics61--

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