Warning letter
Specialty Health Products CO, LLC: warning letter of Jul 7, 2026
FDA warning letter 726564 · Center for Devices and Radiological Health
Key facts
| Reference number | 726564 |
|---|---|
| Company | Specialty Health Products CO, LLC |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jul 7, 2026 |
| Posted date | Sep 22, 2026 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 876.5220(b), 876.5220(b)(1), 801, 807.81(a)(3)(ii), 801.20(a), 807.81(b), 820, 820.40, 830, 830.3, 830.300(a) |
| Inspection city | Phoenix |
| Inspection ZIP | 85050 |
| Inspection start date | Dec 1, 2025 |
| 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: