FDA Inspection 638774 — Ephraim McDowell Health IRB
The FDA completed an inspection of Ephraim McDowell Health IRB on January 6, 2010 in Danville, KY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 6, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Danville, KY (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7316 | 21 CFR 56.115(a)(4) | Copies of IRB/CI correspondence |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7320 | 21 CFR 56.109(e) | IRB approvals/disapprovals - general |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |
| 7339 | 21 CFR 56.108(a)(4) | Changes in approved research |
| 7340 | 21 CFR 56.108(a)(3) | Prompt reporting of changes |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |
| 7343 | 21 CFR 56.108(b)(3) | Reporting of suspension/termination |
| 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 |