FDA Inspection
Amita Health IRBAmita Health IRB – FDA Inspection, Dec 12, 2013
Record Details
This FDA Inspection record concerns Amita Health IRB, with an inspection on December 12, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Amita Health IRB
- Inspection Date
- December 12, 2013
- Product Type
- Devices
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ID · e73d764a-188c-4bb7-94f2-759645aa2bc1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 856798
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.109(b)Information given to subjects
- 21 CFR 56.110(b)(2)Minor changes
- 21 CFR 56.110(c)Method to keep members advised
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Other FDA inspections of Amita Health IRB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 23, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 23, 2015 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| August 17, 2009 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Amita Health IRB
- FDA Inspection 1068795 - 2018-08-23
- FDA Inspection 931564 - 2015-06-23
- FDA Inspection 605963 - 2009-08-17
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