FDA Inspection 1201259 — AlloSource
The FDA completed an inspection of AlloSource on March 30, 2023 in Centennial, CO. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 30, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Centennial, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12345 | 21 CFR 1271.190(b)(1) | Clean, sanitary, orderly manner |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |