# FDA 483 - Endogastric Solutions, Inc. - February 29, 2012

Source: https://www.globalkeysolutions.net/records/483/endogastric-solutions-inc/2fc8742e-a288-4833-b2f3-7b7652abe9f0

> FDA 483 for Endogastric Solutions, Inc. on February 29, 2012. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Endogastric Solutions, Inc.
- Inspection Date: 2012-02-29
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Endogastric Solutions, Inc. in Redwood City, CA, was inspected regarding its role as a sponsor of an investigational device study. The inspection revealed significant deficiencies in study monitoring, reporting to IRBs and FDA, informed consent processes, and investigator qualifications. These issues led to protocol violations, continued subject enrollment after a study hold, and a lack of proper oversight procedures.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sandra-saniga/a1a89397-a095-46de-9355-aa1cd88d729a)

Company: https://www.globalkeysolutions.net/companies/endogastric-solutions-inc/b8806a36-41f7-4f70-b901-2d16c322f121

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b