Louisville City Wire

There were two companies in a city associated with Jefferson County, Kentucky, that received two FDA inspections in August, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 100% increase over the number of companies inspected in the previous month, when one company received one inspection.

The companies inspected were involved in either the Biologics or Devices sectors.

There was one company in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions. One should take voluntary action to correct the organization's management 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	Result
Isopure, Corp.	Devices	08/15/2024	Voluntary Action Indicated (VAI)
University of Louisville Health - University of Louisville Hospital	Biologics	08/20/2024	No Action Indicated (NAI)