Warning letter
Genesis Biosystems, Inc: warning letter of Sep 21, 2015
FDA warning letter 451146 · Dallas District Office
Key facts
| Reference number | 451146 |
|---|---|
| Company | Genesis Biosystems, Inc |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | Sep 21, 2015 |
| Posted date | Oct 13, 2015 |
| Issuing office | Dallas District Office |
| Product type | Devices |
| CFR sections cited | 878.9(b), 878.4820, 820, 807.81(b), 880.6960 |
| Inspection city | Lewisville |
| Inspection ZIP | 75057 |
| Inspection start date | Dec 8, 2014 |
| 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: