Company
United StatesHackensack University Medical Center, Hackensack, NJ – FDA Inspections
Inspection records and compliance data for Hackensack University Medical Center in Hackensack, New Jersey. 8 FDA inspections on record, 1 Form 483, last inspected September 17, 2024.
Company Profile
This profile covers Hackensack University Medical Center based in Hackensack, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 3
- NAI
- 5
- Form 483s
- 1
- Warning letters
- 0
First inspected March 29, 2010. Last inspected September 17, 2024.
Most cited issue areas
- Arm preparation2 inspections
- Procedures re complaints1 inspection
- Process validation procedures1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 17, 2024 | NAI | Biologics · Blood and Blood Products | 1249540 |
| February 17, 2022 | NAI | Biologics · Vaccines and Allergenic Products | 1162878 |
| April 4, 2018 | NAI | Biologics · Blood and Blood Products | 1047629 |
| September 29, 2017 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1027008 |
| March 10, 2016 | NAI | Biologics · Blood and Blood Products | 962090 |
| July 9, 2014 | NAI | Biologics · Blood and Blood Products | 887607 |
| January 24, 2012 | VAI | Biologics · Blood and Blood Products | 763288 |
| March 29, 2010 | VAI | Biologics · Blood and Blood Products | 654875 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Hackensack University Medical Center
FEI Number
2271937
Address
30 Prospect Ave, Hackensack, New Jersey 07601, United States
Country
United States
ID: e4892a14-f7eb-459b-8a97-82abf141c418