FDA inspection
Hardy Diagnostics: FDA inspection ending Jun 9, 2023
FDA inspection 1207738 · Voluntary Action Indicated (VAI) · Santa Maria, CA
Key facts
| Inspection ID | 1207738 |
|---|---|
| Firm | Hardy Diagnostics |
| FEI number | 2022807 |
| Address | 1430 W McCoy Ln |
| City | Santa Maria |
| State | CA |
| ZIP | 93455 |
| Country | United States |
| Fiscal year | 2023 |
| Inspection end date | Jun 9, 2023 |
| 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