Warning letter
Yangzhou Sion Commodity Co., Ltd.: warning letter of Mar 12, 2025
FDA warning letter 699183 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 699183 |
|---|---|
| Company | Yangzhou Sion Commodity Co., Ltd. |
| Subject | CGMP/Finished Pharmaceutical/API/Adulterated |
| Issue date | Mar 12, 2025 |
| Posted date | Mar 25, 2025 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 211.22, 211.25(a), 211.84, 211.84(d)(1), 211.165(b), 211.166, 211.194(a) |
| Inspection city | Yangzhou |
| Inspection start date | Sep 23, 2024 |
| 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: