Warning letter
Atossa Genetics, Inc.: warning letter of Feb 20, 2013
FDA warning letter 342078 · Seattle District Office
Key facts
| Reference number | 342078 |
|---|---|
| Company | Atossa Genetics, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Issue date | Feb 20, 2013 |
| Posted date | Feb 20, 2013 |
| Issuing office | Seattle District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 807.97, 807.81(a)(3)(i), 820, 807.81(b) |
| Inspection city | Seattle |
| Inspection ZIP | 98102 |
| Inspection start date | Jul 16, 2012 |
| 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: