Biomat USA, Incorporated – FDA 483, Feb 18, 2026

Biomat USA, Incorporated in Taylorsville, UT, a source plasma firm, was cited for significant deficiencies in its plasma collection processes and quality systems. The inspection revealed failures in equipment qualification leading to uninvestigated donor overdraws, inadequate investigation of discrepancies and adverse donor reactions, and insufficient standard operating procedures for blood collection and donor safety. These issues indicate a severe lack of control over critical operations impacting donor safety and product quality.