FDA Inspection
Covenant Medical Center Inc. IRBCovenant Medical Center Inc. IRB – FDA Inspection, Apr 20, 2011
Record Details
This FDA Inspection record concerns Covenant Medical Center Inc. IRB, with an inspection on April 20, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 20, 2011
- Product Type
- Drugs
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ID · 1588ffaa-4474-48df-be76-a8899b4751ec
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 722593
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
15- 21 CFR 56.115(a)(5)List of members
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
- 21 CFR 50.25(a)(1)Statement of research, purpose, duration of participation
- 21 CFR 50.25(a)(7)Whom to contact
- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 56.111(b)Vulnerable subject safeguards
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
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Other FDA inspections of Covenant Medical Center Inc. IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 2, 2012 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Covenant Medical Center Inc. IRB
- FDA Inspection 1060863 - 2018-07-12
- FDA Inspection 779781 - 2012-05-02
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