FDA 483 - Montefiore Medical Center Blood Bank - April 29, 2025

An FDA inspection of Montefiore Medical Center's Blood Bank in Bronx, NY, revealed significant deficiencies in record-keeping and adherence to standard operating procedures. Observations included untraceable blood products, incomplete irradiation records, undocumented product movements, and failures in quality control documentation. These issues indicate a concerning lack of control over critical processes for blood and blood components.