483
Montefiore Medical Center Blood BankFDA 483 - Montefiore Medical Center Blood Bank - April 29, 2025
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Record Details
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.
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ID · 821bb032-715d-4850-81b5-11c6f47f9e35