FDA 483 - Biomat USA, Inc. - June 18, 2025

An FDA inspection of DB Biologics, LLC in Harrisburg, PA, a source plasma donor center, revealed a significant issue regarding the preparation of phlebotomy sites. The firm failed to ensure sterile venipuncture sites for donor blood collections, as phlebotomists were observed palpating prepared areas before proceeding with collections. This practice compromises the sterility of blood products.