FDA inspection
PROFOUND MEDICAL INC.: FDA inspection ending Sep 17, 2018
FDA inspection 1131987 · Voluntary Action Indicated (VAI) · Mississauga
Key facts
| Inspection ID | 1131987 |
|---|---|
| Firm | PROFOUND MEDICAL INC. |
| FEI number | 3012604011 |
| Address | 2400 Skymark Ave Unit 6 |
| City | Mississauga |
| Fiscal year | 2018 |
| Inspection end date | Sep 17, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data