FDA Inspection 862365 — Eurofins Donor & Product Testing LLC
The FDA completed an inspection of Eurofins Donor & Product Testing LLC on January 14, 2014 in Centennial, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 14, 2014
- Fiscal Year
- 2014
- 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 |
| 12320 | 21 CFR 1271.160(b)(3) | Actions verified, short and long term solutions |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |