Montclair Hospital, LLC, Montclair, NJ – FDA Inspections

Inspection records and compliance data for Montclair Hospital, LLC in Montclair, New Jersey. 5 FDA inspections on record, last inspected February 22, 2018.

Company Profile

This profile covers Montclair Hospital, LLC based in Montclair, New Jersey, United States.

FDA Inspection History

FDA inspections: 5
OAI: 0
VAI: 1
NAI: 4
Form 483s: 0
Warning letters: 0

First inspected October 13, 2010. Last inspected February 22, 2018.

Most cited issue areas

Equipment calibration frequency1 inspection
Establish, maintain and follow manufacturing SOPs1 inspection
Quality control unit review of records1 inspection

FDA inspections (5)

Date	Result	FDA center(s)	Insp. #
February 22, 2018	NAI	Biologics · Blood and Blood Products	1042444
January 14, 2016	NAI	Biologics · Blood and Blood Products	956171
March 20, 2014	NAI	Biologics · Blood and Blood Products	871109
June 13, 2012	NAI	Biologics · Blood and Blood Products	787300
October 13, 2010	VAI	Biologics · Blood and Blood Products	694534

FDA documents

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

Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

GenVault

Reproductive Science Center of New Jersey, P.A.

New York Blood Center, Inc.

Celularity, Inc. dba LifebankUSA

Department of Veterans Affairs N.J. Health Care System

RWJ Barnabas Health/Trinitas Regional Medical Center (Blood Bank)

Dendreon Corporation

Vertical Spine, LLC

Plasma Services Group, Inc

Central Jersey Blood Center, Inc.