FDA Inspection 1025002 — Xenex Laboratories Inc.
The FDA completed an inspection of Xenex Laboratories Inc. on Sep 12, 2017 in Coquitlam. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 12, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Coquitlam (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |