Warning letter
ASI Medical, Inc.: warning letter of Jan 23, 2013
FDA warning letter 370803 · Center for Devices and Radiological Health
Key facts
| Reference number | 370803 |
|---|---|
| Company | ASI Medical, Inc. |
| Subject | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| Issue date | Jan 23, 2013 |
| Posted date | Jan 23, 2013 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 807.81(b) |
| Inspection city | Englewood |
| Inspection ZIP | 80112 |
| Inspection start date | Dec 19, 2011 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- NAI 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: