# FDA 483 - Tusker Medical, Inc. - October 08, 2019

Source: https://www.keypedia.com/records/483/tusker-medical-inc/3f31a19d-b470-48b0-b673-233b7c9f10b6

> FDA 483 for Tusker Medical, Inc. on October 08, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Tusker Medical, Inc.
- Inspection Date: 2019-10-08
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Tusker Medical, Inc. in Menlo Park, CA, was cited for deficiencies related to its conduct as a sponsor of investigational studies. Observations included failures in developing and adhering to a study monitoring plan, submitting monitoring visit reports late, and utilizing unqualified monitors. Additionally, the firm shipped investigational devices to a principal investigator prior to obtaining site IRB approval and device ship authorization.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/tusker-medical-inc/9a2fea56-66c2-4c67-8e0f-5673e9182ec3)

## Related Officers

- [investigator](https://www.keypedia.com/people/dustin-r-abaonza/0a9994bd-d6ab-47cc-8f1b-5bf4d10bd852)

Company: https://www.keypedia.com/companies/tusker-medical-inc/d207e0c7-a113-4326-9e53-ca68fba99a9c

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