FDA inspection
Theken Companies LLC: FDA inspection ending Dec 13, 2018
FDA inspection 1074413 · Voluntary Action Indicated (VAI) · Akron, OH
Key facts
| Inspection ID | 1074413 |
|---|---|
| Firm | Theken Companies LLC |
| FEI number | 3002498892 |
| Address | 1800 Triplett Blvd |
| City | Akron |
| State | OH |
| ZIP | 44306 |
| Country | United States |
| Fiscal year | 2019 |
| Inspection end date | Dec 13, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: 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