Warning letter
Deltex Pharmaceuticals Inc: warning letter of Oct 31, 2008
FDA warning letter 28607 · Dallas District Office
Key facts
| Reference number | 28607 |
|---|---|
| Company | Deltex Pharmaceuticals Inc |
| Subject | CGMP/Otc Drug Products/Adulterated |
| Issue date | Oct 31, 2008 |
| Posted date | Oct 31, 2008 |
| Issuing office | Dallas District Office |
| Product type | Drugs |
| CFR sections cited | 201.66, 201.115, 211, 211.192, 341, 211.22(d), 211.84(d)(2), 211.113(a), 211.160(b), 211.160(b)(1), 211.165(b), 211.186(b)(9) |
| Inspection city | Rosenberg |
| Inspection ZIP | 77471-3038 |
| Inspection start date | Jun 9, 2008 |
| 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: