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Jefferson Reporter

Monday, December 23, 2024

FDA: 1 company in cities within Jefferson County received 2 citations in Q1

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Vid Desai FDA’s Chief Information Officer | Official Website

Vid Desai FDA’s Chief Information Officer | Official Website

There was one company in a city associated with Jefferson County that received FDA citations as a result of one inspection conducted in the county over the first quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is unchanged from the number of companies cited in the previous quarter.

The citations in the county were 'Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been adequately established' and 'Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established'.

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 Jefferson County Cities and the citations they received in Q1
Company NameArea of BusinessInspection DateIssue Cited
Vulcan Custom DentalDevices01/10/2024Procedures for product review,disposition lack of/inadequate
Vulcan Custom DentalDevices01/10/2024Lack of or inadequate complaint procedures

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