FDA Inspection 664330 — Eurofins Donor & Product Testing LLC
The FDA completed an inspection of Eurofins Donor & Product Testing LLC on May 28, 2010 in Centennial, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 28, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Centennial, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12309 | 21 CFR 1271.160(a) | Program is appropriate for the HCT/Ps |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 161 | 21 CFR 606.160(a)(2) | Determination of lot numbers and supplies |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 93 | 21 CFR 606.100(b)(14) | QC procedures for supplies and reagents |
| 98 | 21 CFR 606.100(c) | Thorough investigations |