FDA Inspection 840877 — EndoGastric Solutions, Inc.
The FDA completed an inspection of EndoGastric Solutions, Inc. on July 9, 2013 in Redmond, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 9, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Redmond, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |