FDA Inspection
EndoGastric Solutions, Inc.EndoGastric Solutions, Inc. – FDA Inspection, Sep 30, 2009
Record Details
This FDA Inspection record concerns EndoGastric Solutions, Inc., with an inspection on September 30, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- EndoGastric Solutions, Inc.
- Inspection Date
- September 30, 2009
- Product Type
- Devices
View Company Profile
ID · 4ba2ea56-5f4b-45e3-83db-bc184edb2b8c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 620289
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(b)Incoming inspection, testing, verification
- 21 CFR 820.100(b)Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of EndoGastric Solutions, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 6, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 14, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 9, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 25, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 9, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for EndoGastric Solutions, Inc.
- FDA Inspection 1181876 - 2022-10-06
- FDA Inspection 945409 - 2015-10-14
- FDA Inspection 840877 - 2013-07-09
- FDA Inspection 818401 - 2013-01-25
- FDA Inspection 713028 - 2011-02-09
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