FDA Inspection
Hackensack University Medical CenterHackensack University Medical Center – FDA Inspection, Mar 29, 2010
Record Details
This FDA Inspection record concerns Hackensack University Medical Center, with an inspection on March 29, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 29, 2010
- Product Type
- Biologics
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ID · 360ea931-8212-4620-8c4f-fc67d26a4756
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 654875
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 21 CFR 640.4(f)Arm preparation
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Other FDA inspections of Hackensack University Medical Center
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 17, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| April 4, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 29, 2017 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 10, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Hackensack University Medical Center
- FDA Inspection 1249540 - 2024-09-17
- FDA Inspection 1162878 - 2022-02-17
- FDA Inspection 1047629 - 2018-04-04
- FDA Inspection 1027008 - 2017-09-29
- FDA Inspection 962090 - 2016-03-10
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