FDA Inspection 756111 — KEDPLASMA LLC
The FDA completed an inspection of KEDPLASMA LLC on Nov 23, 2011 in Gallup, NM. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 23, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Gallup, NM (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 368 | 21 CFR 640.72(d) | Donor reaction |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |