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483
•Long Island Jewish Medical Center•March 15, 2024

Long Island Jewish Medical Center – FDA 483, Mar 15, 2024

Record Details

An FDA inspection of Long Island Jewish Medical Center's blood bank identified three observations related to record-keeping and adherence to standard operating procedures. Issues included inaccurate documentation of personnel performing tests and preparation times for blood products, as well as failures in maintaining irradiator malfunction logs. Additionally, the facility did not consistently follow procedures for the visual inspection of blood products prior to issuance for transfusion.

Company
Long Island Jewish Medical Center
Inspection date
March 15, 2024
Product type
biologics
Office
Division of Human and Animal Food Operations - East I
Person
  • Irina Gaberman (Investigator)
View Company Profile

ID · 164661e2-970e-49d5-a92b-ee8838e5ad86

Other documents for Long Island Jewish Medical Center
  • 483 - 2026-05-01May 1, 2026
  • 483 - 2022-03-10March 10, 2022

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