FDA Inspection 544221 — AlloSource
The FDA completed an inspection of AlloSource on Oct 3, 2008 in Tracy, CA. 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). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 3, 2008
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Tracy, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12339 | 21 CFR 1271.180(c) | Availability of procedures |
| 12365 | 21 CFR 1271.195(d) | Documentation not maintained |
| 12370 | 21 CFR 1271.200(c) | Calibration procedures and schedules (general) |
| 12402 | 21 CFR 1271.230(c) | Changes to validated process |
| 12429 | 21 CFR 1271.265(d) | Shipping conditions appropriate |