Warning letter
Iso-Tex Diagnostics, Inc.: warning letter of Nov 8, 2001
FDA warning letter UCM178400 · Dallas District Office
Key facts
| Reference number | UCM178400 |
|---|---|
| Company | Iso-Tex Diagnostics, Inc. |
| Subject | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated |
| Issue date | Nov 8, 2001 |
| Posted date | Nov 8, 2001 |
| Issuing office | Dallas District Office |
| Product type | Drugs |
| CFR sections cited | 211.46(c), 211.46(b), 211.113(b), 211.166(b), 211.137(a), 211.180(e), 211.194(e), 211.198(a), 310.305(a), 314.80(b) |
| Country | 3 |
| Inspection city | Alvin |
| Inspection ZIP | 77511-1466 |
| Inspection start date | Oct 2, 2001 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: