FDA Inspection 836511 — Gift of Hope - Organ & Tissue Donor Network
The FDA completed an inspection of Gift of Hope - Organ & Tissue Donor Network on July 12, 2013 in Itasca, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 12, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Itasca, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12338 | 21 CFR 1271.180(b) | Review and approval-responsible person |