NW Franklin News

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

This is an increase over the number of companies cited in the previous quarter.

The citations in the county include:

• Procedures for management review have not been adequately established.
• Procedures for quality audits have not been adequately established.
• Validation of device software is inadequate.

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
IncludeHealth	Devices	11/01/2023	Management review - Lack of or inadequate procedures
IncludeHealth	Devices	11/01/2023	Quality audits - Lack of or inadequate procedures
IncludeHealth	Devices	11/01/2023	Design validation - software validation not performed
IncludeHealth	Devices	11/01/2023	Lack of or inadequate procedures
IncludeHealth	Devices	11/01/2023	Lack of or inadequate complaint procedures