The FDA sent a letter to Globus Medical in July warning the devicemaker about an inspection related to the Excelsius GPS spine robot.
The letter, which was posted on the FDA's website Aug. 13, said an inspection found the devices "are adulterated," not conforming with current manufacturing practice requirements.
Daniel Paul, senior vice president of quality assurance and information technology responded to the FDA's concerns in March and May, the letter said. The FDA noted violations including failure to implement corrective and preventative procedures and failure to review and investigate complaints involving "the possible failure of a device to meet any of its specifications."
Globus Medical shared data related to misplaced screws, but the FDA's letter alleges that the devicemaker didn't use further data analysis to spot trends. The agency also alleged Globus Medical didn't follow the product complaint procedure.
Globus Medical filed a Form 8-K Aug. 13 commenting on the letter, and it said the company has "taken corrective actions and provided a comprehensive and timely response to the FDA. We believe the FDA’s concerns set forth in the warning letter have been or can be resolved without a material impact to our operations or financial results."
"Globus Medical has provided a formal response to the FDA, which included more requested details and action plans the company intends to perform to address the FDA’s concerns," a spokesperson for the company told Becker's. "This was completed within the required 15 days from issuance of the warning letter. We are confident that we have the data and documentation to support swift resolution in this matter."