FDA Inspection
Porter, Littleton and Parker Adventist Hospitals Joint IRBPorter, Littleton and Parker Adventist Hospitals Joint IRB – FDA Inspection, May 11, 2010
Record Details
This FDA Inspection record concerns Porter, Littleton and Parker Adventist Hospitals Joint IRB, with an inspection on May 11, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 11, 2010
- Product Type
- Drugs
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ID · b055d07c-b1de-4f64-9cfa-373563e05aa8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 662070
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.108(a)(4)Changes in approved research
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Other FDA inspections of Porter, Littleton and Parker Adventist Hospitals Joint IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2016 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 18, 2012 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Porter, Littleton and Parker Adventist Hospitals Joint IRB
- FDA Inspection 981513 - 2016-05-19
- FDA Inspection 811086 - 2012-12-18
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