Jefferson Reporter

There was one company in a city associated with Shelby 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.

Company Name	Area of Business	Inspection Date	Issue Cited
Vulcan Custom Dental	Devices	01/10/2024	Procedures for product review,disposition lack of/inadequate
Vulcan Custom Dental	Devices	01/10/2024	Lack of or inadequate complaint procedures