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

An FDA inspection of Biomat USA, Inc. in Allentown, PA, conducted from February 10-13, 2025, identified a significant issue regarding phlebotomy site preparation. Specifically, a phlebotomist was observed palpating a venipuncture site without proper re-scrubbing, which could compromise the sterility of collected blood. This observation indicates a potential risk to donor safety and product quality.