FDA Inspection 1100689 — DonorConnect
The FDA completed an inspection of DonorConnect on Aug 20, 2019 in Murray, UT. 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). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 20, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Murray, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12384 | 21 CFR 1271.215 | Potential problems with recovery |