Warning letter
Q’Apel Medical, Inc.: warning letter of Feb 5, 2025
FDA warning letter 699244 · Center for Devices and Radiological Health
Key facts
| Reference number | 699244 |
|---|---|
| Company | Q’Apel Medical, Inc. |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | Feb 5, 2025 |
| Posted date | Mar 11, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820, 820.40, 803, 807.81(a)(3), 807.81(b) |
| Inspection city | Fremont |
| Inspection ZIP | 94538 |
| Inspection start date | Jul 29, 2024 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
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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: