FDA Inspection
Hackensack Meridian Health IRBHackensack Meridian Health IRB – FDA Inspection, Jun 1, 2009
Record Details
This FDA Inspection record concerns Hackensack Meridian Health IRB, with an inspection on June 1, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 1, 2009
- Product Type
- Drugs
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ID · 3e8873ba-fb29-450d-9b93-f446bc09ebaf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 585506
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
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Other FDA inspections of Hackensack Meridian Health IRB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 24, 2025 | Not classified | New Jersey District Office | |
| December 17, 2019 | NAI | Bioresearch Monitoring | |
| February 11, 2014 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Hackensack Meridian Health IRB
- FDA Inspection 1293604 - 2025-11-24
- FDA Inspection 1115851 - 2019-12-17
- FDA Inspection 866795 - 2014-02-11
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