FDA 483 - Lifesouth Community Blood Centers - Montgomery Region - April 14, 2025

Lifesouth Community Blood Centers - Montgomery Region was inspected and cited for significant deficiencies in phlebotomy site preparation, investigation of ABO blood grouping discrepancies, and quality control procedures for supplies and reagents. The observations indicate a lack of adherence to manufacturer instructions, internal SOPs, and federal regulations, potentially impacting the sterility of blood products and accuracy of blood typing.