# FDA 483 - Rodo Medical Inc - August 01, 2014

Source: https://www.keypedia.com/records/483/rodo-medical-inc/11b10fe9-e467-460e-8004-88148c07010e

> FDA 483 for Rodo Medical Inc on August 01, 2014. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rodo Medical Inc
- Inspection Date: 2014-08-01
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Rodo Medical, Inc. in Sunnyvale, CA, was inspected regarding its role as a sponsor of an investigational device study. The inspection revealed significant deficiencies in the conduct and documentation of a clinical study for the RODO Attachment Device, including initiating the study without FDA approval and lacking proper investigator qualifications and oversight. These issues indicate a severe lack of adherence to regulatory requirements for investigational device studies and human subject protection.

## Related Officers

- [investigator](https://www.keypedia.com/people/sherri-n-rohlf/41090ab1-83d1-4e95-92ea-0cfca5cecdb6)

Company: https://www.keypedia.com/companies/rodo-medical-inc/2035bb27-880c-49b3-bda4-a5839a763a00

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