FDA 483 - Biomat USA, Inc. - February 13, 2025

An FDA inspection of Biomat USA, Inc. in Allentown, PA, a source plasma donor center, revealed one observation related to inadequate phlebotomy site preparation. Specifically, a phlebotomist was observed palpating a venipuncture site after initial preparation without re-scrubbing, which could compromise the sterility of the blood collection.