Warning letter
APS (USA) Ltd.: warning letter of May 24, 2000
FDA warning letter UCM068469 · Center for Devices and Radiological Health
Key facts
| Reference number | UCM068469 |
|---|---|
| Company | APS (USA) Ltd. |
| Subject | Action Potential Stimulation Therapy Device/Promotional Claims/Lacks Premarket Approval/Misbranded |
| Issue date | May 24, 2000 |
| Posted date | May 24, 2000 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 807.81(a) |
| Country | 3 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
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: