FDA Inspection 886543 — Faxton St. Lukes Healthcare IRB
The FDA completed an inspection of Faxton St. Lukes Healthcare IRB on Jun 27, 2014 in Utica, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 27, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Utica, NY (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7277 | 21 CFR 56.107(d) | One non-affiliate member |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7334 | 21 CFR 56.115(a)(5) | List of members |