FDA Inspection 980778 — Eurofins Donor & Product Testing LLC
The FDA completed an inspection of Eurofins Donor & Product Testing LLC on February 19, 2016 in Centennial, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 19, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Centennial, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12288 | 21 CFR 1271.80(c) | Manufacturer instructions not followed |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12342 | 21 CFR 1271.190(a) | Size, construction, location--prevent mix-ups etc. |
| 12359 | 21 CFR 1271.195(a)(3) | Aseptic processing---cleaning, disinfecting |
| 12362 | 21 CFR 1271.195(b) | Corrective actions |
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12370 | 21 CFR 1271.200(c) | Calibration procedures and schedules (general) |
| 12395 | 21 CFR 1271.225 | Verification/validation |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |