FDA Inspection 621686 — Joslin Diabetes Center Committee on Human Studies
The FDA completed an inspection of Joslin Diabetes Center Committee on Human Studies on October 2, 2009 in Boston, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 2, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Boston, MA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7369 | 21 CFR 56.109(h) | Children as subjects |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |