Louisville City Wire

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 second quarter of 2024, 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 quarter.

The citations in the county were 'Documentation of equipment maintenance, cleaning, sanitization, and calibration was not maintained' and 'Storage temperatures of HCT/Ps were not maintained'.

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
Alpha Orthopedic Systems, LLC	Biologics	04/29/2024	Documentation of maintenance and cleaning
Alpha Orthopedic Systems, LLC	Biologics	04/29/2024	Storage temperatures recorded, maintained