FDA Inspection 722593 — Covenant Medical Center Inc. IRB
The FDA completed an inspection of Covenant Medical Center Inc. IRB on April 20, 2011 in Saginaw, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 20, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Saginaw, MI (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7278 | 21 CFR 56.107(e) | Conflict of interest |
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7328 | 21 CFR 56.111(b) | Vulnerable subject safeguards |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7368 | 21 CFR 56.108(a)(2) | More frequent reviews, verification of no changes |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |
| 7387 | 21 CFR 50.25(a)(1) | Statement of research, purpose, duration of participation |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |
| 7392 | 21 CFR 50.25(a)(7) | Whom to contact |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |