Warning letter
Iso-Tex Diagnostics, Inc.: warning letter of Jul 20, 2023
FDA warning letter 655666 · Division of Pharmaceutical Quality Operations II
Key facts
| Reference number | 655666 |
|---|---|
| Company | Iso-Tex Diagnostics, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jul 20, 2023 |
| Posted date | Aug 1, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations II |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.42(a), 211.42(c)(10)(iv), 211.113(b), 211.160(b) |
| Inspection city | Alvin |
| Inspection ZIP | 77511 |
| Inspection start date | Jan 30, 2023 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: