FDA Inspection
Mercy Research IRBMercy Research IRB – FDA Inspection, Jun 15, 2015
Record Details
This FDA Inspection record concerns Mercy Research IRB, with an inspection on June 15, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Mercy Research IRB
- Inspection Date
- June 15, 2015
- Product Type
- Drugs
View Company Profile
ID · 57c7c6ba-ed71-4d62-b0bc-e2caff07f363
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 930451
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 50.25(a)(2)Reasonably foreseeable risks or discomforts
- 21 CFR 50.25(a)(4)Alternate procedures, courses of treatment
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Other FDA inspections of Mercy Research IRB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2022 | NAI | Bioresearch Monitoring | |
| February 16, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 23, 2009 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Mercy Research IRB
- FDA Inspection 1170288 - 2022-04-11
- FDA Inspection 1045009 - 2018-02-16
- FDA Inspection 559346 - 2009-01-23
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