FDA 483 - Jarvis Surgical, Inc. - July 07, 2022

Jarvis Surgical, Inc., a medical device contract manufacturer in Westfield, MA, was cited for failing to establish procedures to prevent contamination. The firm routinely used a commonly known allergen, which is a restricted substance per quality agreements and customer requirements, in the manufacturing processes for hip, shoulder, knee, and spine implants. This indicates a significant lapse in contamination control and quality system adherence.