FDA inspection
Louisville APL Diagnostics, Inc.: FDA inspection ending Dec 19, 2022
FDA inspection 1193146 · Voluntary Action Indicated (VAI) · Texas City, TX
Key facts
| Inspection ID | 1193146 |
|---|---|
| Firm | Louisville APL Diagnostics, Inc. |
| FEI number | 1000305932 |
| Address | 702 9th St N Ste A |
| City | Texas City |
| State | TX |
| ZIP | 77590 |
| Country | United States |
| Fiscal year | 2023 |
| Inspection end date | Dec 19, 2022 |
| 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