FDA Inspection 682294 — Vitalant
The FDA completed an inspection of Vitalant on September 27, 2010 in Montvale, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 27, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Montvale, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 224 | 21 CFR 640.4(f) | Arm preparation |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |