FDA Inspection 620289 — EndoGastric Solutions, Inc.
The FDA completed an inspection of EndoGastric Solutions, Inc. on September 30, 2009 in Redmond, WA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 30, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Redmond, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3268 | 21 CFR 820.80(b) | Incoming inspection, testing, verification |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |