Warning letter
Seatex, LLC: warning letter of Apr 1, 2024
FDA warning letter 672951 · Division of Pharmaceutical Quality Operations II
Key facts
| Reference number | 672951 |
|---|---|
| Company | Seatex, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Apr 1, 2024 |
| Posted date | May 21, 2024 |
| Issuing office | Division of Pharmaceutical Quality Operations II |
| Product type | Drugs |
| CFR sections cited | 211.22, 211.192, 211.67(b), 211.84(d)(1) |
| Inspection city | Rosenberg |
| Inspection ZIP | 77471 |
| Inspection start date | Oct 16, 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: