FDA Inspection 810455 — AMD Medicom Inc.
The FDA completed an inspection of AMD Medicom Inc. on Dec 13, 2012 in Montreal. 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: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 13, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Montreal (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 2431 | 21 CFR 820.30(b) | Design plans- updated |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |