FDA Inspection
Oeyama-Moto Medical FoundationOeyama-Moto Medical Foundation – FDA Inspection, Sep 29, 2015
Record Details
This FDA Inspection record concerns Oeyama-Moto Medical Foundation, with an inspection on September 29, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 29, 2015
- Product Type
- Drugs
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ID · 0f7039b3-e08e-4bd0-bc96-ad3d5269ae90
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 947368
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
11- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.115(a)(3)Records of continuing review
- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 56.109(e)IRB approvals/disapprovals - general
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(a)(2)More frequent reviews, verification of no changes
- 21 CFR 56.108(a)(3)Prompt reporting of changes
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
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Other FDA inspections of Oeyama-Moto Medical Foundation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2018 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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