FDA Inspection 762659 — Our Lady Of Bellefonte Hosp IRB
The FDA completed an inspection of Our Lady Of Bellefonte Hosp IRB on January 6, 2012 in Ashland, KY. 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
- January 6, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Ashland, KY (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7316 | 21 CFR 56.115(a)(4) | Copies of IRB/CI correspondence |
| 7317 | 21 CFR 56.115(a)(1) | Copies of all research proposals and related documents |
| 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 |
| 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 |
| 7684 | 21 CFR 56.106(b)(2) | IRB chairperson information |
| 7686 | 21 CFR 56.106(b)(3) | Number of active protocols |
| 7687 | 21 CFR 56.106(b)(4) | Description of types of products |