FDA Inspection 955900 — Willis-Knighton Health System IRB
The FDA completed an inspection of Willis-Knighton Health System IRB on Jan 28, 2016 in Shreveport, LA. 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
- Jan 28, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Shreveport, LA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7324 | 21 CFR 56.111(a)(4) | Informed consent sought |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |