FDA Inspection 1028845 — Eurofins PROXY Laboratories B.V.
The FDA completed an inspection of Eurofins PROXY Laboratories B.V. on September 7, 2017 in Leiden. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 7, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Leiden (Netherlands)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |