Warning letter
Aqualex Co., Ltd.: warning letter of Jun 12, 2024
FDA warning letter 672292 · Center for Drug Evaluation and Research | CDER
Key facts
| Reference number | 672292 |
|---|---|
| Company | Aqualex Co., Ltd. |
| Subject | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Adulterated |
| Issue date | Jun 12, 2024 |
| Posted date | Jun 18, 2024 |
| Issuing office | Center for Drug Evaluation and Research | CDER |
| Product type | Drugs |
| CFR sections cited | 201.128, 211.22, 211.34, 211.63, 201.66(b)(2), 201.66(b)(5), 211.100(a), 211.165(b), 211.166(a), 201.66(c)(2) |
| Inspection city | Seongnam |
| Inspection start date | Oct 16, 2023 |
| Letter on fda.gov | fda.gov |
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: