Warning letter
Xoran Technologies, LLC: warning letter of Dec 9, 2024
FDA warning letter 694229 · Center for Devices and Radiological Health
Key facts
| Reference number | 694229 |
|---|---|
| Company | Xoran Technologies, LLC |
| Subject | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Issue date | Dec 9, 2024 |
| Posted date | Jan 14, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820, 820.3(b), 807.81(b) |
| Inspection city | Ann Arbor |
| Inspection ZIP | 48108 |
| Inspection start date | Jun 25, 2024 |
| 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: