FDA Inspection 702415 — ImpactLife
The FDA completed an inspection of ImpactLife on December 16, 2010 in Davenport, IA. 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
- December 16, 2010
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Davenport, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9262 | 21 CFR 610.40(b) | One or more approved screening tests |