Warning letter
Next Science LLC: warning letter of Feb 21, 2025
FDA warning letter 698114 · Center for Devices and Radiological Health
Key facts
| Reference number | 698114 |
|---|---|
| Company | Next Science LLC |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Feb 21, 2025 |
| Posted date | Apr 1, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 807.81(b), 820, 803, 803.3(w), 803.50(a)(1) |
| Inspection city | Jacksonville |
| Inspection ZIP | 32256-2805 |
| Inspection start date | Aug 12, 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: