FDA Inspection
The Queen's Medical Center IRBThe Queen's Medical Center IRB – FDA Inspection, May 6, 2009
Record Details
This FDA Inspection record concerns The Queen's Medical Center IRB, with an inspection on May 6, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 6, 2009
- Product Type
- Devices
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ID · bea360ce-8589-4fd0-8c19-3aadc31b71e0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 583294
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
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Other FDA inspections of The Queen's Medical Center IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 21, 2017 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for The Queen's Medical Center IRB
- FDA Inspection 1239051 - 2024-04-11
- FDA Inspection 1025042 - 2017-07-21
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