Warning letter
Spectra Therapy, LLC: warning letter of Jul 22, 2025
FDA warning letter 698026 · Center for Devices and Radiological Health
Key facts
| Reference number | 698026 |
|---|---|
| Company | Spectra Therapy, LLC |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jul 22, 2025 |
| Posted date | Aug 12, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803.17(a)(2), 803.17(b), 830, 830.3, 820, 820.40, 801.20(a), 803.50(a), 803.50(b)(3), 807.81(b), 801, 803 and 8 more |
| Inspection city | Port Huron |
| Inspection ZIP | 48060 |
| Inspection start date | Sep 10, 2024 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: