FDA Inspection 773542 — DonorConnect
The FDA completed an inspection of DonorConnect on March 8, 2012 in Murray, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 8, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Murray, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12291 | 21 CFR 1271.80(d)(2) | Plasma diluted test specimens |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12340 | 21 CFR 1271.180(d) | Adopted from another organization |
| 12359 | 21 CFR 1271.195(a)(3) | Aseptic processing---cleaning, disinfecting |
| 12384 | 21 CFR 1271.215 | Potential problems with recovery |
| 12472 | 21 CFR 1271.350(b)(1) | Deviations not investigated |