FDA 483 - Biomat USA Inc - November 06, 2025

An FDA inspection of Biomat USA Inc in Killeen, TX, from November 3-6, 2025, revealed a significant failure to perform thorough investigations into unexplained discrepancies. Specifically, the firm's CAPA investigations did not adequately address an employee's deliberate entry of false quality control results for donor hematocrit testing, nor did they fully correct repeated failures to record cannula lot numbers for collected source plasma. These issues indicate serious deficiencies in the firm's quality system and investigation processes, potentially impacting donor eligibility and product safety.