FDA 483 - Somersault Orthopedics, Inc. - February 26, 2015

Somersault Orthopedics, Inc. in Pleasanton, CA, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to validate critical manufacturing processes for knee cutting guides and lacked established procedures for in-process product acceptance and corrective and preventive actions. Additionally, the company did not submit required Medical Device Reports for device malfunctions and had no written MDR procedures in place.