Warning letter
ASI Medical, Inc. [ARCHIVED]: warning letter of Apr 20, 2011
FDA warning letter 161895 · Denver District Office
Key facts
| Reference number | 161895 |
|---|---|
| Company | ASI Medical, Inc. [ARCHIVED] |
| Subject | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated |
| Issue date | Apr 20, 2011 |
| Posted date | Apr 20, 2011 |
| Issuing office | Denver District Office |
| Product type | Devices |
| CFR sections cited | 181, 820 |
| Inspection city | Englewood |
| Inspection ZIP | 80112 |
| Inspection start date | Nov 18, 2010 |
| 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: