FDA Inspection 794613 — KEDPlasma LLC
The FDA completed an inspection of KEDPlasma LLC on August 8, 2012 in Lincoln, NE. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 8, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Lincoln, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3246 | 21 CFR 640.61 | Obtaining consent in an appropriate manner |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |