FDA Inspection 745825 — Vitalant
The FDA completed an inspection of Vitalant on September 16, 2011 in Albuquerque, NM. 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
- September 16, 2011
- Fiscal Year
- 2011
- 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 |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |