FDA Inspection
EndoGastric Solutions, Inc.EndoGastric Solutions, Inc. – FDA Inspection, Jul 9, 2013
Record Details
This FDA Inspection record concerns EndoGastric Solutions, Inc., with an inspection on July 9, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- EndoGastric Solutions, Inc.
- Inspection Date
- July 9, 2013
- Product Type
- Devices
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ID · a511977f-c5f8-4e93-bbe7-d5b845d9f0b8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 840877
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
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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 |
| January 25, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 9, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 30, 2009 | OAI | 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 818401 - 2013-01-25
- FDA Inspection 713028 - 2011-02-09
- FDA Inspection 620289 - 2009-09-30
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