Warning letter
Endogastric Solutions Inc [ARCHIVED]: warning letter of Mar 12, 2010
FDA warning letter 87145 · Seattle District Office
Key facts
| Reference number | 87145 |
|---|---|
| Company | Endogastric Solutions Inc [ARCHIVED] |
| Subject | Medical Device Reporting (MDR) Regulation Misbranded/Adulterated |
| Issue date | Mar 12, 2010 |
| Posted date | Mar 12, 2010 |
| Issuing office | Seattle District Office |
| Product type | Devices |
| CFR sections cited | 803.50(a)(2), 803, 803.17, 807.81(b) |
| Inspection city | Redmond |
| Inspection ZIP | 98052 |
| Inspection start date | Sep 11, 2009 |
| 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: