Warning letter
Myotronics-Noromed Inc.: warning letter of Apr 9, 2012
FDA warning letter 210154 · Seattle District Office
Key facts
| Reference number | 210154 |
|---|---|
| Company | Myotronics-Noromed Inc. |
| Subject | Medical Device Lacks Premarket approval/Misbranded |
| Issue date | Apr 9, 2012 |
| Posted date | Apr 9, 2012 |
| Issuing office | Seattle District Office |
| Product type | Devices |
| CFR sections cited | 807.81(b) |
| Inspection city | Kent |
| Inspection ZIP | 98032 |
| Inspection start date | Apr 25, 2011 |
| Letter on fda.gov | web.archive.org |
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: