VA New York Harbor Healthcare SystemJanuary 29, 2025

FDA 483 - VA New York Harbor Healthcare System - January 29, 2025

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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.

Company: VA New York Harbor Healthcare System
Inspection Date: January 29, 2025
Product Type: Biologics
Office: New York District Office
Person: Irina Gaberman (Investigator)

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ID · cda85486-0463-400a-87e4-475ac4c8557b