FDA Inspection 1006999 — Eurofins Chemical Analysis Pty Ltd
The FDA completed an inspection of Eurofins Chemical Analysis Pty Ltd on March 24, 2017 in Dandenong South. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 24, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dandenong South (Australia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |