FDA Inspection 906359 — Southern College Of Optometry IRB
The FDA completed an inspection of Southern College Of Optometry IRB on Nov 11, 2014 in Memphis, TN. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 11, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Memphis, TN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7339 | 21 CFR 56.108(a)(4) | Changes in approved research |
| 7358 | 21 CFR 50.55(a) | Adequate provisions for assent of children |
| 7390 | 21 CFR 50.25(a)(4) | Alternate procedures, courses of treatment |