FDA Inspection 1010063 — AlloSource
The FDA completed an inspection of AlloSource on February 9, 2017 in Centennial, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 9, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Centennial, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12343 | 21 CFR 1271.190(a) | State of repair |
| 12387 | 21 CFR 1271.220(a) | Causing contamination, increasing risks |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |
| 12411 | 21 CFR 1271.260(a) | Contamination, mix ups, improper release |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 537 | 21 CFR 820.70(a) | Production processes |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |