Joco Today

There were five companies in cities associated with Johnson County that received FDA citations as a result of five inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is unchanged from the number of companies cited in the previous year.

Of the 14 citations issued, the most common citations were 'Design validation did not ensure the device conforms to defined user needs and intended uses' and 'Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed'.

Most of the companies cited were involved in the Devices sector.

All of the 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
Eurofins Viracor, LLC.	Devices	04/19/2023	Design verification - output does not meet input requirement
Eurofins Viracor, LLC.	Devices	04/19/2023	Design validation - user needs and intended uses
Eurofins Viracor, LLC.	Devices	04/19/2023	Lack of or inadequate procedures
Eurofins Viracor, LLC.	Devices	04/19/2023	Lack of or inadequate complaint procedures
Examinetics, Inc.	Devices	10/05/2023	Quality Audit/Reaudit - conducted
Examinetics, Inc.	Devices	10/05/2023	Design validation - user needs and intended uses
KUPI Reproductive Endocrinology & Infertility Lab	Biologics	03/06/2023	Risk factors, clinical evidence
The Peavey Corporation	Devices	01/10/2023	Management review - Lack of or inadequate procedures
The Peavey Corporation	Devices	01/10/2023	Quality audits - Lack of or inadequate procedures
The Peavey Corporation	Devices	01/10/2023	Training records
The Peavey Corporation	Devices	01/10/2023	Purchasing controls, Lack of or inadequate procedures
The Peavey Corporation	Devices	01/10/2023	Lack of or inadequate process validation
TriRx Shawnee, LLC	Drugs	12/15/2023	Procedures for sterile drug products
TriRx Shawnee, LLC	Veterinary	12/15/2023	Procedures for sterile drug products