Newark Beth Israel Medical Center - Blood Bank, Newark, NJ – FDA Inspections

Inspection records and compliance data for Newark Beth Israel Medical Center - Blood Bank in Newark, New Jersey. 9 FDA inspections on record, 1 Form 483, last inspected April 22, 2026.

Company Profile

This profile covers Newark Beth Israel Medical Center - Blood Bank based in Newark, New Jersey, United States.

FDA Inspection History

FDA inspections: 9
OAI: 0
VAI: 2
NAI: 7
Form 483s: 1
Warning letters: 0

First inspected March 20, 2009. Last inspected April 22, 2026.

Most cited issue areas

Establish, maintain and follow manufacturing SOPs2 inspections
Concurrent documentation1 inspection
Equipment observed, standardized, calibrated1 inspection

FDA inspections (9)

Date	Result	FDA center(s)	Insp. #
April 22, 2026	NAI	· Blood and Blood Products	1314854
October 13, 2023	VAI	Biologics · Blood and Blood Products	1220208
April 26, 2022	NAI	Biologics · Vaccines and Allergenic Products	1168186
July 26, 2018	NAI	Biologics · Blood and Blood Products	1061410
September 22, 2016	NAI	Biologics · Blood and Blood Products	989086
July 15, 2014	NAI	Biologics · Blood and Blood Products	887560
August 30, 2012	NAI	Biologics · Blood and Blood Products	796990
March 21, 2011	VAI	Biologics · Blood and Blood Products	713382
March 20, 2009	NAI	Biologics · Blood and Blood Products	573088

FDA documents

Form 483s (1)

Form 483s · October 13, 2023

People (1)

Amy W. Yan-Mai

Person

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