FDA Inspection 810579 — KEDPlasma LLC
The FDA completed an inspection of KEDPlasma LLC on Dec 5, 2012 in Williamsville, NY. 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). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 5, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Williamsville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 110 | 21 CFR 606.120(b)(2) | Destruction of obsolete labels |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 9044 | 21 CFR 600.10(b) | Personnel capabilities |