Warning letter
Wello Inc.: warning letter of Nov 8, 2023
FDA warning letter 664806 · Center for Devices and Radiological Health
Key facts
| Reference number | 664806 |
|---|---|
| Company | Wello Inc. |
| Subject | CGMP/QSR/Medical Devices/Misbranded |
| Issue date | Nov 8, 2023 |
| Posted date | Nov 14, 2023 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 801.40(a)(2), 801, 801.3, 830, 830.3, 801.40(a)(1), 801.20(a), 830.300(a) |
| Inspection city | Addison |
| Inspection ZIP | 75001 |
| Inspection start date | Jun 15, 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: