FDA Inspection 837091 — ImpactLife
The FDA completed an inspection of ImpactLife on June 14, 2013 in Davenport, IA. 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
- June 14, 2013
- Fiscal Year
- 2013
- 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 |
| 207 | 21 CFR 640.3(a) | Donor suitability not performed on day of collection |
| 35 | 21 CFR 606.40 | Clean & orderly |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9235 | 21 CFR 630.40(c) | Documentation |
| 98 | 21 CFR 606.100(c) | Thorough investigations |