FDA Inspection 993762 — Intertek Testing Services Australia Pty Ltd
The FDA completed an inspection of Intertek Testing Services Australia Pty Ltd on November 3, 2016 in West Footscray. 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
- November 3, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- West Footscray (Australia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1 | 21 CFR 11 | Electronic records |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |