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483
•Lenox Hill Hospital•April 1, 2024

Lenox Hill Hospital – FDA 483, Apr 1, 2024

Record Details

An FDA inspection of Lenox Hill Hospital's Blood Bank in New York, NY, revealed significant deficiencies in record-keeping practices. The hospital failed to maintain concurrent records for the distribution of blood and blood components, particularly concerning emergency releases from a satellite facility and discrepancies in electronic system entries. Additionally, the inspection found a lack of records verifying the proper functioning of new scanners used in the blood bank's electronic system.

Company
Lenox Hill Hospital
Inspection date
April 1, 2024
Product type
biologics
Office
Division of Human and Animal Food Operations - East I
Person
  • Irina Gaberman (Investigator)
View Company Profile

ID · 2ef9c4e4-0bee-4ebc-8ae2-478e9977442a

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