FDA Inspection 808877 — Vitalant
The FDA completed an inspection of Vitalant on November 30, 2012 in Albuquerque, NM. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 30, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Albuquerque, NM (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 255 | 21 CFR 640.31 | Donor eligibility |
| 260 | 21 CFR 640.31(b) | Criteria for plasmapheresis donor eligibility |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |