Knox Times

There was one company in a city associated with Knox County that received FDA citations as a result of one inspection conducted in the county in September, 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 month.

The citations in the county were 'Donor screening of HCT/P donors considered eligible indicated that the donor was not free of risk factors for infection due to communicable disease agents' and 'HCT/Ps for which the applicable donor eligibility requirements were not met were not prominently labeled with the appropriate warning statements'.

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
Fertility Center, LLC	Biologics	09/18/2024	Donor screening standards
Fertility Center, LLC	Biologics	09/18/2024	Eligibility not required--warning labels