FDA Inspection 1115698 — Hansamed Ltd.
The FDA completed an inspection of Hansamed Ltd. on Jan 23, 2020 in Laval. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 23, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Laval (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |