FDA 483 - Biomat USA, Inc. - December 13, 2024

An FDA inspection of Biomat USA, Inc.'s Source Plasma Center in Terre Haute, IN, revealed that written standard operating procedures for blood and blood component collection were not consistently followed. Observations included failures in donor identification prior to venipuncture and improper verification of applicant donor addresses. These findings indicate procedural deficiencies in critical donor screening and collection processes.