FDA Inspection
Ethical & Independent Review Services, LLCEthical & Independent Review Services, LLC – FDA Inspection, Apr 25, 2012
Record Details
This FDA Inspection record concerns Ethical & Independent Review Services, LLC, with an inspection on April 25, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 25, 2012
- Product Type
- Devices
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ID · 80f1a719-157e-4ac0-afbf-8ca0356ca753
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 783754
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 21 CFR 56.115(a)(1)Copies of all research proposals and related documents
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.115(a)(3)Records of continuing review
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
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Other FDA inspections of Ethical & Independent Review Services, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 25, 2010 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Ethical & Independent Review Services, LLC
- FDA Inspection 1091690 - 2019-04-18
- FDA Inspection 649553 - 2010-02-25
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