Lubbock Times

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

This is a 50% decrease from the number of companies cited in the previous year.

The citations in the county include:

• Procedures were not designed to ensure compliance with the donor eligibility requirements.
• Donor eligibility procedures were not reviewed and approved by a responsible person before implementation.
• Donors were not tested for evidence of infection with relevant communicable disease agents.

All of the companies cited were involved in the Biologics sector.

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
Pelex Medical of Texas	Biologics	07/28/2023	Design of procedures to ensure compliance
Pelex Medical of Texas	Biologics	07/28/2023	Review and approval of procedures
Pelex Medical of Texas	Biologics	07/28/2023	Infection with communicable disease agents
Texas Technician University Health Sciences Center Center for Fertility and Reproductive Surgery	Biologics	07/26/2023	Testing, screening, donor eligibility procedures
Texas Technician University Health Sciences Center Center for Fertility and Reproductive Surgery	Biologics	07/26/2023	Summary--records used to make determination
Texas Technician University Health Sciences Center Center for Fertility and Reproductive Surgery	Biologics	07/26/2023	Completion of eligibility determination
Texas Technician University Health Sciences Center Center for Fertility and Reproductive Surgery	Biologics	07/26/2023	Kits not FDA approved, specifically labeled