FDA inspection
Lusys Laboratories, Inc.: FDA inspection ending Sep 24, 2021
FDA inspection 1152920 · Official Action Indicated (OAI) · San Diego, CA
Key facts
| Inspection ID | 1152920 |
|---|---|
| Firm | Lusys Laboratories, Inc. |
| FEI number | 3004473533 |
| Address | 6620 Mesa Ridge Rd Ste 100 |
| City | San Diego |
| State | CA |
| ZIP | 92121 |
| Country | United States |
| Fiscal year | 2021 |
| Inspection end date | Sep 24, 2021 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 625807 |
At a glance
- 1–9 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