FDA Inspection 1006999 — Eurofins BioPharma Product Testing Australia Pty Ltd.
The FDA completed an inspection of Eurofins BioPharma Product Testing Australia Pty Ltd. on Mar 24, 2017 in Dandenong South. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 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 |