483
VA New York Harbor Healthcare SystemVA New York Harbor Healthcare System – FDA 483, Jan 29, 2025
Record Details
An FDA inspection of VA New York Harbor Healthcare System's Blood Bank in Brooklyn, NY, revealed a significant failure to maintain adequate records. The facility did not document investigations or corrective actions for discrepancies in patient testing results and lacked documentation for over-temperature alarm checks on critical units. These findings indicate deficiencies in quality control and record-keeping practices.
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