FDA Inspection 1090119 — Eurofins Donor & Product Testing LLC
The FDA completed an inspection of Eurofins Donor & Product Testing LLC on May 17, 2019 in Centennial, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 17, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Centennial, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12343 | 21 CFR 1271.190(a) | State of repair |
| 12351 | 21 CFR 1271.190(d)(1) | Procedures for cleaning, sanitation |
| 12370 | 21 CFR 1271.200(c) | Calibration procedures and schedules (general) |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |