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

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.