Warning letter
Iso-Tex Diagnostics, Inc [ARCHIVED]: warning letter of Dec 3, 2010
FDA warning letter 133350 · Dallas District Office
Key facts
| Reference number | 133350 |
|---|---|
| Company | Iso-Tex Diagnostics, Inc [ARCHIVED] |
| Subject | CGMP for Finished Pharmaceuticals/Adulterated |
| Issue date | Dec 3, 2010 |
| Posted date | Dec 3, 2010 |
| Issuing office | Dallas District Office |
| Product type | Drugs |
| CFR sections cited | 211.192, 211.42(c)(10)(i), 211.46(c), 211.113(b), 314.70(b)(3)(vii) |
| Inspection city | Alvin |
| Inspection ZIP | 77511 |
| Inspection start date | May 4, 2010 |
| Letter on fda.gov | web.archive.org |
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: