Joco Today

There were two companies in cities associated with Johnson County that received FDA citations as a result of two inspections 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.

Of the four citations issued, the most common citation was 'Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed'.

Both companies cited should take voluntary actions to correct their 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
Examinetics, Inc.	Devices	10/05/2023	Quality Audit/Reaudit - conducted
Examinetics, Inc.	Devices	10/05/2023	Design validation - user needs and intended uses
TriRx Shawnee, LLC	Drugs	12/15/2023	Procedures for sterile drug products
TriRx Shawnee, LLC	Veterinary	12/15/2023	Procedures for sterile drug products