FDA inspection
Ark Bio Medical Canada Corp: FDA inspection ending Jul 17, 2015
FDA inspection 938545 · Official Action Indicated (OAI) · North Milton
Key facts
| Inspection ID | 938545 |
|---|---|
| Firm | Ark Bio Medical Canada Corp |
| FEI number | 3005656725 |
| Address | 671 Rustico Rd - Rte 7 |
| City | North Milton |
| Country | Canada |
| Fiscal year | 2015 |
| Inspection end date | Jul 17, 2015 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 516211 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes 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