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Monday, December 23, 2024

FDA: 1 company in cities within Linn County received 2 citations in 2023

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Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

There was one company in a city associated with Linn County that received FDA citations as a result of one inspection conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 50% decrease from the number of companies cited in the previous year.

The citations in the county were 'A device master record has not been adequately maintained' and 'The device history record does not include, or refer to the location of any unique device identifier (UDI) or universal product code (UPC)'.

The company cited should take a voluntary action to correct its managing operations.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Companies Located Within Linn County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Dental Prosthetic Services, Inc.Devices04/20/2023DMR - not or inadequately maintained
Dental Prosthetic Services, Inc.Devices04/20/2023DHR - UDI not included

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