FDA Inspection
Hackensack University Medical CenterHackensack University Medical Center – FDA Inspection, Sep 29, 2017
Record Details
This FDA Inspection record concerns Hackensack University Medical Center, with an inspection on September 29, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · c0fe8099-d599-44e9-844c-1690f5869ab7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1027008
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.230(a)Process validation procedures
Full citation text and observation details available on the Dashboard.
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 |
| March 10, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 9, 2014 | 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 962090 - 2016-03-10
- FDA Inspection 887607 - 2014-07-09
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