FDA inspection
DNA Genotek Inc.: FDA inspection ending Sep 20, 2013
FDA inspection 851753 · Official Action Indicated (OAI) · Kanata
Key facts
| Inspection ID | 851753 |
|---|---|
| Firm | DNA Genotek Inc. |
| FEI number | 3003742580 |
| Address | 3000-500 Palladium Dr |
| City | Kanata |
| Country | Canada |
| Fiscal year | 2013 |
| Inspection end date | Sep 20, 2013 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 416225 |
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