Bergen Comm Reg Blood Center, Montvale, NJ – FDA Inspections

Inspection records and compliance data for Bergen Comm Reg Blood Center in Montvale, New Jersey. 8 FDA inspections on record, last inspected July 10, 2026.

Company Profile

This profile covers Bergen Comm Reg Blood Center based in Montvale, New Jersey, United States.

FDA Inspection History

FDA inspections: 8
OAI: 0
VAI: 2
NAI: 6
Form 483s: 0
Warning letters: 0

First inspected September 27, 2010. Last inspected July 10, 2026.

Most cited issue areas

Establish, maintain and follow manufacturing SOPs2 inspections
Qualifications of responsible personnel2 inspections
Concurrent documentation1 inspection

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
July 10, 2026	NAI	· Blood and Blood Products	1326740
January 25, 2023	NAI	Biologics · Blood and Blood Products	1196618
February 4, 2019	NAI	Biologics · Blood and Blood Products	1078963
March 31, 2017	NAI	Biologics · Blood and Blood Products	1009279
July 19, 2016	NAI	Biologics · Blood and Blood Products	978304
May 15, 2014	VAI	Biologics · Blood and Blood Products	878690
March 14, 2012	VAI	Biologics · Blood and Blood Products	773806
September 27, 2010	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	682294

FDA documents

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

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