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Hawkeye Reporter

Tuesday, November 5, 2024

Iowa: Device companies were the third most FDA inspected companies in Iowa in Q1 2023

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James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

In the first quarter of 2023, four device companies received four FDA inspections in Iowa, according to the U.S. Food and Drug Administration (FDA).

This was the third highest number of inspections per type of company made by the FDA in Iowa, equalling 8.3% of all inspections in the first quarter of 2023.

Of all the Iowa companies involved in the device sector, Rockwell Medical, Inc. and Mission Systems Davenport, Inc. received the most citations from the FDA in the first 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 Iowa During Q1 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring11--
Blood and Blood Products3----
Compliance: Devices22--
Food Composition, Standards, Labeling and Econ2----
Foodborne Biological Hazards141--
Monitoring of Marketed Animal Drugs, Feed, and Devices231--
Postmarket Assurance: Devices4----
Technical Assistance: Food and Cosmetics1----
Vaccines and Allergenic Products3----

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