Talecris Plasma Resources (Biomat USA, Inc.) – FDA 483, May 1, 2025

Between April 28 and May 1, 2025, the Food and Drug Administration (FDA) conducted a regulatory inspection of the Talecris Plasma Resources (Biomat USA, Inc.) facility located in El Paso, Texas. This Source Plasma Donor Center was evaluated under the authority of Section 704(b) of the Federal Food, Drug, and Cosmetic Act to ensure compliance with safety and sterility standards.

The inspection identified significant procedural failures regarding the preparation of phlebotomy sites. Specifically, the FDA investigator observed that staff members were not following the facility's established Standard Operating Procedures (SOPs) for venipuncture and plasma collection. Key violations included phlebotomists failing to allow the required drying time for antiseptic solutions before drawing blood and neglecting to re-sanitize the site when the delay between preparation and venipuncture exceeded the maximum allowable time. Additionally, the inspection noted that blood pressure cuffs were positioned in a manner that interfered with the sterile preparation area.

These lapses in protocol undermine the assurance of a sterile collection environment, potentially risking the safety of both the donors and the plasma products. As the Form 483 represents preliminary findings rather than a final agency decision, the company is expected to respond. Talecris Plasma Resources must either provide evidence to contest the observations or submit a comprehensive corrective action plan to the FDA to address these sterility concerns and improve operational compliance.