FDA 483 - BioLife Plasma Services L.P. - February 20, 2026

BioLife Plasma Services L.P., located in Kokomo, Indiana, was subject to an FDA inspection from February 10 to February 20, 2026. The inspection identified three primary violations concerning the facility’s operations as a source plasma establishment. First, the quality control unit failed to conduct thorough investigations into recurring discrepancies. Specifically, staff repeatedly failed to scan essential "soft goods"—such as needles, saline, and collection containers—into the donor information system. Despite numerous scanning omissions recorded since January 2025, no formal corrective action plans were implemented. Second, the facility failed to maintain concurrent records for significant steps in the plasma collection process, which prevented the accurate tracing of materials used during procedures. Finally, the firm distributed plasma products produced with new automated equipment and collection containers without submitting the required notification to the FDA at least 30 days prior to distribution. These observations were issued under the regulatory framework of Section 704(b) of the Food, Drug, and Cosmetic Act. Although these findings do not constitute a final agency determination, BioLife Plasma Services is expected to respond to the FDA with a detailed plan for corrective actions to address these procedural gaps and ensure future compliance with safety standards.