FDA Inspection 889761 — Eurofins BioPharma Product Testing ENCO, LLC
The FDA completed an inspection of Eurofins BioPharma Product Testing ENCO, LLC on Jul 11, 2014 in Cary, NC. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 11, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cary, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 17857 | 21 CFR 212.60(f) | Lab written procedures |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |