FDA inspection
Helica Instruments, Ltd.: FDA inspection ending Nov 11, 2015
FDA inspection 949799 · Official Action Indicated (OAI) · Edinburgh
Key facts
| Inspection ID | 949799 |
|---|---|
| Firm | Helica Instruments, Ltd. |
| FEI number | 3003824921 |
| Address | Longstone, 102 Kingsknowe Road North |
| City | Edinburgh |
| Country | United Kingdom |
| Fiscal year | 2016 |
| Inspection end date | Nov 11, 2015 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 491658 |
At a glance
- 10–99 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