FDA inspection
Iso-Tex Diagnostics, Inc.: FDA inspection ending Feb 10, 2023
FDA inspection 1197186 · Official Action Indicated (OAI) · Alvin, TX
Key facts
| Inspection ID | 1197186 |
|---|---|
| Firm | Iso-Tex Diagnostics, Inc. |
| FEI number | 1626310 |
| Address | 1511 County Road 129 |
| City | Alvin |
| State | TX |
| ZIP | 77511 |
| Country | United States |
| Fiscal year | 2023 |
| Inspection end date | Feb 10, 2023 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 655666 |
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
- 10–99 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