FDA inspection
The Hygenic Company LLC.: FDA inspection ending Dec 17, 2021
FDA inspection 1161392 · Voluntary Action Indicated (VAI) · Akron, OH
Key facts
| Inspection ID | 1161392 |
|---|---|
| Firm | The Hygenic Company LLC. |
| FEI number | 1519375 |
| Address | 1245 Home Ave |
| City | Akron |
| State | OH |
| ZIP | 44310 |
| Country | United States |
| Fiscal year | 2022 |
| Inspection end date | Dec 17, 2021 |
| 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