FDA inspection
Alpha Tekniko: FDA inspection ending Dec 14, 2017
FDA inspection 1034999 · Voluntary Action Indicated (VAI) · Lake Zurich, IL
Key facts
| Inspection ID | 1034999 |
|---|---|
| Firm | Alpha Tekniko |
| FEI number | 3007798904 |
| Address | 1290 Ensell Rd |
| City | Lake Zurich |
| State | IL |
| ZIP | 60047 |
| Country | United States |
| Fiscal year | 2018 |
| Inspection end date | Dec 14, 2017 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
At a glance
- 1–9 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