FDA Inspection 891981 — National Cancer Institute, Cancer Therapy Evaluation Program
The FDA completed an inspection of National Cancer Institute, Cancer Therapy Evaluation Program on July 17, 2014 in Bethesda, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 17, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Bethesda, MD (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7410 | 21 CFR 312.53(a) | Investigator selection |
| 7411 | 21 CFR 312.53(c)(1) | Investigator statement (FDA 1572) |
| 7479 | 21 CFR 312.56(a) | Monitoring investigations |
| 7554 | 21 CFR 312.53(c)(4) | Financial information - sufficient and accurate |