FDA Inspection 945409 — EndoGastric Solutions, Inc.

EndoGastric Solutions, Inc. — FEI 3005473391

The FDA completed an inspection of EndoGastric Solutions, Inc. on October 14, 2015 in Redmond, WA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
October 14, 2015
Fiscal Year
2016
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Redmond, WA (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures