FDA Inspection 825227 — Vitalant
The FDA completed an inspection of Vitalant on May 22, 2013 in Rosemont, IL. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 22, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Rosemont, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 9236 | 21 CFR 630.40(b)(1) | Deferred or not eligible |