The FDA issued a warning letter to Globus Medical, Inc., highlighting serious regulatory violations following an inspection of their Pennsylvania facility.

The firm manufactures the Excelsius GPS surgical robot, a Class II medical device. The inspection, conducted from February to March 2024, revealed that the company’s practices did not meet the required quality standards, leading to the devices being classified as adulterated under U.S. law. Key violations include failure to implement corrective and preventive actions, inadequate complaint investigations, and delays in mandatory medical device reporting (MDR). Despite the company’s responses, the FDA found their corrective actions insufficient. The FDA emphasized the need for prompt action to address these issues, warning that failure to comply could result in severe regulatory actions, including product seizures, injunctions, and penalties. The letter serves as a critical reminder for Globus Medical to thoroughly investigate and resolve the identified deficiencies to ensure compliance with FDA regulations.