Warning letter
Sanitation & Environmental Technology Institute dba SDWH: warning letter of Sep 10, 2024
FDA warning letter 687970 · Center for Devices and Radiological Health
Key facts
| Reference number | 687970 |
|---|---|
| Company | Sanitation & Environmental Technology Institute dba SDWH |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Sep 10, 2024 |
| Posted date | Sep 11, 2024 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 58, 58.35, 58.202, 58.29(a), 58.35(b)(5), 58.90(b), 58.185(a)(9), 58.31(c), 58.33(a) |
| Inspection city | Suzhou |
| Inspection start date | Mar 6, 2024 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- 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: