Warning letter
Stat Medical Devices, Inc. [ARCHIVED]: warning letter of Apr 17, 2009
FDA warning letter 49279 · Florida District Office
Key facts
| Reference number | 49279 |
|---|---|
| Company | Stat Medical Devices, Inc. [ARCHIVED] |
| Subject | CGMP/QSR/Adulterated/Misbranded |
| Issue date | Apr 17, 2009 |
| Posted date | Apr 17, 2009 |
| Issuing office | Florida District Office |
| Product type | Devices |
| CFR sections cited | 806.10(a), 803, 803.3, 803.50, 806.10, 803.50(a)(2), 807.81(a)(3)(i), 820, 820.1(a)(3), 807.81(b) |
| Inspection city | North Miami Beach |
| Inspection ZIP | 33162 |
| Inspection start date | Dec 3, 2008 |
| Letter on fda.gov | web.archive.org |
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: