FDA 483 - Gauss Surgical, Inc. - July 18, 2019

Gauss Surgical, Inc. in Los Altos, CA, was inspected by the FDA from July 15-18, 2019. The inspection revealed significant deficiencies in the firm's quality system, including inadequate documentation of labels for reworked products, failure to maintain product acceptance status, and insufficient procedures for controlling environmental conditions to protect products from degradation. These issues indicate a lack of control over product quality and labeling.