Overlook Medical Center - Blood Bank, Summit, NJ – FDA Inspections

Inspection records and compliance data for Overlook Medical Center - Blood Bank in Summit, New Jersey. 7 FDA inspections on record, last inspected January 30, 2025.

Company Profile

This profile covers Overlook Medical Center - Blood Bank based in Summit, New Jersey, United States.

FDA Inspection History

FDA inspections: 7
OAI: 0
VAI: 3
NAI: 3
Unclassified: 1
Form 483s: 0
Warning letters: 0

First inspected March 13, 2009. Last inspected January 30, 2025.

Most cited issue areas

Criteria for suitability of reissue of returned blood1 inspection
Donor notification1 inspection
Equipment observed, standardized, calibrated1 inspection

FDA inspections (7)

Date	Result	FDA center(s)	Insp. #
January 30, 2025	Not classified	Biologics	1260137
August 12, 2021	NAI	Biologics · Blood and Blood Products	1153615
March 6, 2018	NAI	Biologics · Blood and Blood Products	1043756
September 3, 2015	NAI	Biologics · Blood and Blood Products	941615
June 26, 2013	VAI	Biologics · Blood and Blood Products	838541
May 10, 2011	VAI	Biologics · Blood and Blood Products	723793
March 13, 2009	VAI	Biologics · Blood and Blood Products	570121

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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