FDA Inspection 576044 — Vitalant
The FDA completed an inspection of Vitalant on Mar 13, 2009 in Denver, CO. 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). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 13, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Denver, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 155 | 21 CFR 606.160(b) | Required records |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 63 | 21 CFR 606.65 | Safe, sanitary, orderly storage |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |