FDA Inspection
Alameda Health System IRBAlameda Health System IRB – FDA Inspection, Apr 18, 2014
Record Details
This FDA Inspection record concerns Alameda Health System IRB, with an inspection on April 18, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Alameda Health System IRB
- Inspection Date
- April 18, 2014
- Product Type
- Drugs
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ID · aed105fd-35e3-4890-9072-8f62ebb8a790
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 877320
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
7- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
- 21 CFR 56.110(b)Research not eligible for expedited review
- 21 CFR 56.110(b)(2)Minor changes
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Other FDA inspections of Alameda Health System IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 10, 2019 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| April 10, 2009 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Alameda Health System IRB
- FDA Inspection 1106045 - 2019-10-10
- FDA Inspection 575699 - 2009-04-10
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