Louisville City Wire

There were two companies in a city associated with Jefferson County that received FDA citations as a result of two inspections conducted in the county over the first quarter of 2024, 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:

• A scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
• You did not take a reasonable measure or precaution related to personnel practices.
• Your hazard analysis did not identify a hazard that required a preventive control.

Both companies cited were involved in either Food and Cosmetics or Veterinary sectors.

Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).

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
Thorn BioScience, LLC	Veterinary	01/19/2024	Procedures for sterile drug products
Thorn BioScience, LLC	Veterinary	01/19/2024	Scientifically sound laboratory controls
Thorn BioScience, LLC	Veterinary	01/19/2024	Failing drug products not rejected
Thorn BioScience, LLC	Veterinary	01/19/2024	Investigations of discrepancies, failures
Tova Industries, LLC	Food and Cosmetics	01/16/2024	Scheduled process establishment
Tova Industries, LLC	Food and Cosmetics	01/16/2024	Personnel
Tova Industries, LLC	Food and Cosmetics	01/16/2024	Hazard analysis - Identification of hazard