Dallas City Wire

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

This is a 33.3% increase over the number of companies cited in the previous month.

The citations in the county include:

• Failure of equipment to perform in the manner for which it was designed so as to assure compliance with the official requirements prescribed in 21 CFR 606.
• Testing for communicable disease agents was not performed in accordance with the manufacturer's instructions.
• Corrective actions relating to core CGTP requirements have not been verified to ensure effectiveness and compliance with CGTP and did not include both short term corrective actions to address the immediate deficiency and long term corrective actions to prevent recurrence.

All of the companies cited were involved in the Biologics 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
Dallas IVF	Biologics	03/28/2024	Determination based on screening and testing
Eurofins Donor & Product Testing Dallas, Inc.	Biologics	03/05/2024	Manufacturer instructions not followed
Eurofins Donor & Product Testing Dallas, Inc.	Biologics	03/05/2024	Actions verified, short and long term solutions
Eurofins Donor & Product Testing Dallas, Inc.	Biologics	03/05/2024	Deviations--evaluation, cause, corrective action
Eurofins Donor & Product Testing Dallas, Inc.	Biologics	03/05/2024	Design appropriate, suitably located
Octapharma Plasma, Inc.	Biologics	03/22/2024	Provide proper equipment to meet requirements
Steri-Tek, LLC	Biologics	03/26/2024	Process validation procedures
Steri-Tek, LLC	Biologics	03/26/2024	Storage temperatures recorded, maintained