FDA 483 - Matia Robotics US, Inc. - June 05, 2019

MATH ROBOTICS US INC, a medical device manufacturer in Salt Lake City, UT, was cited for five observations during an FDA inspection. Key issues included a lack of established procedures for design control, purchasing controls, and acceptance activities. Additionally, the firm failed to properly maintain complaint files and conducted internal quality audits with auditors responsible for the audited processes.